Purpose of This PDQ Summary
Overview
General Information
History
Laboratory/Animal/Preclinical Studies
Human/Clinical Studies
Adverse Effects
Level of Evidence for Selected Vegetables/Sun's Soup
Changes to This Summary (01/31/2008)
More Information

Purpose of This PDQ Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of Selected Vegetables/Sun's Soup as a treatment for cancer. The summary is reviewed regularly and updated as necessary by the PDQ Cancer Complementary and Alternative Medicine Editorial Board ¹.

Information about the following is included in this summary:

• A brief history of Selected Vegetables/Sun's Soup research.
• The results of clinical studies of Selected Vegetables/Sun's Soup.
• Possible side effects of Selected Vegetables/Sun's Soup use.

This summary is intended as a resource to inform and assist clinicians and other health professionals who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Some of the reference citations in the summary are accompanied by a level of evidence designation. These designations are intended to help the readers assess the strength of the evidence supporting the use of specific interventions or treatment strategies. The PDQ Cancer Complementary and Alternative Medicine Editorial Board uses a formal evidence ranking system ² in developing its level of evidence designations. These designations should not be used as a basis for reimbursement determinations.

This summary is also available in a patient version ³, which is written in less technical language.

Overview

This complementary and alternative medicine (CAM) information summary provides an overview of the use of Selected Vegetables/Sun’s Soup as an anticancer treatment. The summary includes a brief history of Selected Vegetables/Sun’s Soup and a review of animal and human studies. The information in the Human/Clinical Studies ⁴ section is summarized in a table located at the end of that section.

This summary contains the following key information:

• “Selected Vegetables” and “Sun’s Soup” are names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer. These mixtures were developed by a single individual.



• At present, two formulations of Selected Vegetables/Sun’s Soup are marketed in the United States as dietary supplements.



• The vegetables and herbs in Selected Vegetables/Sun’s Soup are thought to have anticancer and/or immune-system –stimulating properties.



• It has been reported that treatment with Selected Vegetables/Sun’s Soup lengthened the survival of patients with advanced non-small cell lung cancer or other types of malignant tumors. However, different formulations of Selected Vegetables/Sun’s Soup were used in the studies reported to date, making the comparison of results across studies difficult, and design weaknesses in the studies raise doubts about the reliability of the findings.



• Additional clinical studies of Selected Vegetables/Sun’s Soup are being conducted or contemplated.

Many of the medical and scientific terms used in the summary are hypertext linked (at first use in each section) to the NCI Dictionary ⁵, which is oriented toward nonexperts. When a linked term is clicked, a definition will appear in a separate window. All linked terms and their corresponding definitions will appear in a glossary in the printable version of the summary.

Reference citations in some PDQ CAM information summaries may include links to external Web sites that are operated by individuals or organizations for the purpose of marketing or advocating the use of specific treatments or products. These reference citations are included for informational purposes only. Their inclusion should not be viewed as an endorsement of the content of the Web sites, or of any treatment or product, by the PDQ Cancer CAM Editorial Board or the National Cancer Institute (NCI).

General Information

“Selected Vegetables” and “Sun’s Soup” are names given to several different mixtures of vegetables and herbs that have been studied as treatments for cancer and other medical conditions, including acquired immunodeficiency syndrome (AIDS).[1-6] The original formulation contained shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd. (also known by the Chinese herbal name Bai Hua She She Cao), and barbat skullcap ( Scutellaria barbata D. Don, also known by the Chinese herbal name Ban Zhi Lian).[1]

A second formulation, specifically named “Selected Vegetables” (“SV”), was tested in a phase I/II clinical trial that involved patients with advanced non-small cell lung cancer (refer to the Human/Clinical Studies ⁴ section of this summary for more information).[4] SV, which is a freeze-dried vegetable and herb product, is marketed in the United States as a dietary supplement under the names “Freeze-dried SV” or “DSV.”[5]

A third formulation, called “Frozen SV” or “FSV,” has also been studied clinically in patients with advanced non-small cell lung cancer (refer to the Human/Clinical Studies ⁴ section of this summary for more information).[6] FSV, like SV/DSV, is marketed in the United States as a dietary supplement.[5]

In the United States, dietary supplements are regulated as foods, not drugs. Therefore, premarket evaluation and approval by the U.S. Food and Drug Administration (FDA) are not required unless specific disease prevention or treatment claims are made. The FDA can, however, remove from the market dietary supplements that it deems unsafe. It should be noted that no formulation of Selected Vegetables/Sun’s Soup has been approved by the FDA for the treatment of cancer or any other medical condition.

Because dietary supplements are not formally reviewed for manufacturing consistency, there may be considerable variation from lot to lot, and there is no guarantee that ingredients identified on product labels are present in the specified amounts or present at all.

SV/DSV and FSV are reported to contain soybean (Glycine max [L.] Merr.), shiitake mushroom, mung bean, red date (Ziziphus jujuba Miller), scallion (Allium bakeri Regel), garlic (Allium sativum L.), leek (Allium fistulosum L.), lentil (Lens culinaris Medic.), Hawthorn fruit (Crataegus monogyna Jacquin and/or Crataegus oxyacantha L.), onion (Allium cepa L.), ginseng (Panax ginseng C.A. Meyer), Angelica root (Angelica sinensis), licorice (Glycyrrhiza glabra L.), dandelion root (Taraxacum officinale Weber), senega root (Polygala senega L.), ginger (Zingiber officinale Roscoe), olive (Olea europaea L.), sesame seed (Sesamum indicum L.), and parsley (Petroselinum crispum [P. Miller] Nyman ex A.W. Hill).[4,6]

Many of the ingredients in Selected Vegetables/Sun’s Soup were chosen because previous biochemical research and traditional Chinese medicine suggested they contain molecules that have anticancer or immune-system –stimulating activity. Reviewed in [1-6]

Selected Vegetables/Sun’s Soup is administered orally as part of the diet.[1,4,6] Reviewed in [3] Studies in humans have not always specified a dose or an administration schedule [1], but daily doses of 30 g SV/DSV, mixed with water or other soup, or of 10 oz (approximately 283 g) FSV were used in the above-mentioned clinical studies in patients with advanced non-small cell lung cancer.[4,6]

To conduct clinical drug research in the United States, researchers must file an Investigational New Drug (IND) application with the FDA. An IND must also be obtained for clinical evaluation of dietary supplements as agents for the treatment or prevention of disease. Because the IND application process is confidential and because the existence of an IND can be disclosed only by the applicants, it is not known whether an IND currently exists for the study of Selected Vegetables/Sun’s Soup as a treatment for cancer or any other disease.

In this summary, the specific formulation of Selected Vegetables/Sun’s Soup given to individual patients or groups of patients will be identified wherever possible.

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. ⁶ Last accessed November 28, 2007. 
   
   
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. ⁷ Last accessed November 28, 2007. 
   
   
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting - July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. ⁸ Last accessed November 28, 2007. 
   
   
4. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
   
   
5. Sun Farm Vegetable Soup (SV). Milford, Conn: Sun Farm Corporation, 2000. Available online. ⁹ Last accessed November 28, 2007. 
   
   
6. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   

History

Selected Vegetables/Sun’s Soup was first conceived as a treatment for cancer in the mid-1980s. In an effort to help a relative who was diagnosed with stage IV non-small cell lung cancer (metastasis to the left adrenal gland), the developer created a mixture that contained shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap ( Scutellaria barbata D. Don) in the belief that these plant materials had anticancer and/or immune-system –stimulating properties.[1-3] After the relative appeared to benefit from this treatment (the relative was reported to be alive and cancer free more than 13 years [3]), three additional patients (one with stage IV kidney cancer that had metastasized to the lungs, one with stage IV kidney cancer that had metastasized to the liver and to the lungs, and one with stage IV non-small cell lung cancer that had metastasized to the brain) were treated with a variant of the original mixture, i.e., a combination of shiitake mushroom and mung bean.[1] (Note: No explanation has been given for the omission of Hedyotis diffusa and barbat skullcap for these patients.) These additional patients were also said to benefit from vegetable/herb treatment.[1] (Refer to the Human/Clinical Studies ⁴ section of this summary for more information.)

In June 1992, the developer filed a patent application for the “Herbal treatment of malignancy,” and a patent was awarded in August 1995.[1] Also in June 1992, the developer initiated a clinical trial in the Czech Republic to test Selected Vegetables/Sun’s Soup as a treatment for advanced non-small cell lung cancer.[4] A second clinical study (a nonconsecutive case series) that also involved patients with advanced non-small cell lung cancer was completed in 1997.[5] It is unclear, however, when patient accrual for this second study began.[5] In both reports of the clinical study results, the authors concluded that patients who received Selected Vegetables/Sun’s Soup had prolonged survival.[4,5] (Refer to the Human/Clinical Studies ⁴ section of this summary for more information.)

In 1998, the developer reported at a scientific conference that additional patients with various other types of cancer had benefited from treatment with Selected Vegetables/Sun’s Soup.[2] (Refer to the Human/Clinical Studies ⁴ section of this summary for more information.)

As noted previously (in the General Information ¹⁰ section), the proposed mechanism of action for Selected Vegetables/Sun’s Soup involves anticancer and/or immune-system–stimulating activities associated with some of the ingredients. Reviewed in [1-5] The following types of compounds likely found in Selected Vegetables/Sun’s Soup have been investigated for these activities: protease inhibitors and autoclave-resistant factors, which are found in soybeans (Glycine max L. Merr.); plant sterols; saponin; inositol hexaphosphate (IP6); beta-glucans; lectins; coumestans such as coumestrol; and isoflavones such as daidzein, genistein, biochanin A, and formononetin. Reviewed in [4,5]

One beta-glucan found in shiitake mushroom, i.e., lentinan, has been used as an adjunctive therapy for cancer (primarily gastric cancer and colorectal cancer) in Japan.[6,7] Reviewed in [8,9] Treatment with lentinan has been reported to prolong the survival of patients with gastric cancer [6,7] Reviewed in [8,9] and to improve their quality of life.[6] However, lentinan may not be an active component in Selected Vegetables/Sun’s Soup. This compound has a large molecular mass and is believed to have only limited oral bioavailability. Reviewed in [8-10] Therefore, lentinan has usually been given by intravenous injection. Nonetheless, other substances in shiitake mushroom have been identified as having greater oral bioavailability, and these substances have shown anticancer activity in animal experiments. Reviewed in [8,10]

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. ⁶ Last accessed November 28, 2007. 
   
   
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. ⁷ Last accessed November 28, 2007. 
   
   
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting - July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. ⁸ Last accessed November 28, 2007. 
   
   
4. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
   
   
5. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   
6. Nakano H, Namatame K, Nemoto H, et al.: A multi-institutional prospective study of lentinan in advanced gastric cancer patients with unresectable and recurrent diseases: effect on prolongation of survival and improvement of quality of life. Kanagawa Lentinan Research Group. Hepatogastroenterology 46 (28): 2662-8, 1999 Jul-Aug.  [PUBMED Abstract]
   
   
7. Taguchi T: Clinical efficacy of lentinan on patients with stomach cancer: end point results of a four-year follow-up survey. Cancer Detect Prev Suppl 1: 333-49, 1987.  [PUBMED Abstract]
   
   
8. Borchers AT, Stern JS, Hackman RM, et al.: Mushrooms, tumors, and immunity. Proc Soc Exp Biol Med 221 (4): 281-93, 1999.  [PUBMED Abstract]
   
   
9. Kidd PM: The use of mushroom glucans and proteoglycans in cancer treatment. Altern Med Rev 5 (1): 4-27, 2000.  [PUBMED Abstract]
   
   
10. Wasser SP, Weis AL: Therapeutic effects of substances occurring in higher Basidiomycetes mushrooms: a modern perspective. Crit Rev Immunol 19 (1): 65-96, 1999.  [PUBMED Abstract]
    
    

Laboratory/Animal/Preclinical Studies

Only limited information is available from laboratory or animal studies of Selected Vegetables/Sun’s Soup. The developer’s patent document describes four animal experiments that used two mouse tumor models (mouse sarcoma S1509a, which was used in three of the experiments, and mouse Line 1 lung carcinoma, which was used in one experiment) and that evaluated shiitake mushroom (Lentinus edodes [Berk.] Singer), mung bean (Phaseolus radiatus L.), Hedyotis diffusa Willd., and barbat skullcap ( Scutellaria barbata D. Don).[1]

In these experiments, small groups of mice were fed either standard laboratory chow or laboratory chow that had been mixed with one or more of the four named substances. The mice were fed these diets both before and after they received subcutaneous injections of tumor cells. Results presented in the patent document show that tumor growth was slower in mice fed the experimental diets (i.e., containing the substances) than in mice fed standard laboratory chow. However, the greatest inhibition of tumor growth (up to 85% inhibition) was observed in animals fed diets that contained both mung bean and shiitake mushroom.

Results of two additional animal experiments were reported by the developer in a peer-reviewed scientific journal.[2] One experiment was a repetition of the Line 1 lung carcinoma experiment that was described in the developer’s patent document. The results of this experiment were similar to those obtained previously: tumor growth was slower in animals fed the experimental diets, with the greatest inhibition of tumor growth (up to 82% inhibition) observed in animals fed a diet that contained both mung bean and shiitake mushroom.

The second experiment also used the Line 1 lung carcinoma tumor model. In this experiment, tumor growth was measured in mice fed either standard laboratory chow or a mixture of standard laboratory chow and DSV (i.e., the commercially available freeze-dried formulation of Selected Vegetables/Sun’s Soup; refer to the General Information ¹⁰ section of this summary for more information). Tumor growth was approximately 2.3 times slower (i.e., approximately 65% growth inhibition) in mice fed standard laboratory chow plus DSV than in mice fed standard laboratory chow alone.

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. ⁶ Last accessed November 28, 2007. 
   
   
2. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   

Human/Clinical Studies

The following information is summarized in a table ¹¹ located at the end of this section.

The use of Selected Vegetables/Sun’s Soup as a treatment for human cancer has been investigated in only a limited manner. All available resources—the developer’s patent document,[1] the transcript of a presentation made at a scientific conference,[2] the transcript of a meeting of the Cancer Advisory Panel on Complementary and Alternative Medicine (CAPCAM; a joint advisory panel formed by the National Cancer Institute and the National Center for Complementary and Alternative Medicine),[3] and the published reports of two clinical studies [4,5]—have identified fewer than 50 treated patients.

As noted previously (in the History ¹² section), the developer’s patent document describes four patients with advanced cancer who reportedly benefited from treatment with Selected Vegetables/Sun’s Soup.[1] Among the four, three patients were said to have had complete tumor regression. However, two of the four patients were treated concurrently with chemotherapy and radiation therapy, and the remaining two were treated with concurrent chemotherapy.[1,2] Therefore, the actual benefit of Selected Vegetables/Sun’s Soup, if any, to these patients is difficult to determine.

Treatment outcomes for another nine patients were discussed briefly by the developer at a scientific conference in 1998.[2] The exact vegetable/herb combinations given to these individuals were not identified. However, all nine patients reportedly benefited from treatment with Selected Vegetables/Sun’s Soup. Among the nine, three patients (two with metastatic cancer of unspecified primary tumor type and one with metastatic adenocarcinoma of unknown primary tumor origin) did not receive concurrent conventional therapy. Complete tumor regression was observed in two of these three patients.[2] Among the remaining six patients, three (one with metastatic cancer of unspecified primary tumor type, one with prostate cancer, and one with leiomyosarcoma that had metastasized to the lung, the breast, and the armpit) were treated with concurrent conventional therapy (radiation therapy, hormone therapy, and surgery, respectively). Complete tumor regression was observed in the patient with metastatic cancer of unspecified primary tumor type.[2] No information was provided about concurrent treatment for the remaining three individuals (one with prostate cancer and two with colon cancer that had metastasized to the liver).[2] In view of the limited information presented, no conclusions can be drawn about the benefits of Selected Vegetables/Sun’s Soup for these nine patients.

In 1992, the developer initiated a phase I/II clinical trial in the Czech Republic to test Selected Vegetables/Sun’s Soup as a treatment for non-small cell lung cancer.[4] Reviewed in [2,5] The results of this trial were reported in 1999.[4] The trial included a “toxicity arm” to assess the tolerability of long-term administration of Selected Vegetables/Sun’s Soup and a “survival arm” to assess the mixture’s ability to improve survival in patients with advanced disease. Five patients with stage I cancer were included in the toxicity arm; these patients were treated with conventional therapy (surgery plus radiation therapy or radiation therapy alone) in addition to Selected Vegetables/Sun’s Soup. Nineteen patients with stage III or stage IV disease were included in the survival arm; six of these patients were treated with conventional therapy (radiation therapy alone or chemotherapy alone) in addition to Selected Vegetables/Sun’s Soup, and 13 were treated with conventional therapy (radiation therapy alone, chemotherapy alone, surgery plus radiation therapy, or chemotherapy plus radiation therapy) (12 patients) or best supportive care (one patient) but not Selected Vegetables/Sun’s Soup. The remaining 13 patients served as control subjects.

The intended duration of Selected Vegetables/Sun’s Soup treatment for all patients who received the mixture was 24 months. The intended daily dose was 30 g of freeze-dried powder (i.e., DSV; refer to the General Information ¹⁰ section), mixed with water or other soup. Changes in body weight and changes in Karnofsky Performance Status (KPS) were measured in both arms of the trial. Median survival time was the primary endpoint in the survival arm.

In the toxicity arm, all five patients either gained weight or had no change in weight, which was measured twice, i.e., at study entry and 4 to 12 months later. The KPS score, which was also measured twice (at study entry and 3 months later), improved for four of the five patients and remained stable for the fifth. All five individuals were reported to be alive and well 24 months after diagnosis, and none developed a recurrent tumor during follow-up. The actual duration of Selected Vegetables/Sun’s Soup treatment for these patients ranged from more than 17 months to more than 24 months. From these data, the researchers concluded that Selected Vegetables/Sun’s Soup was safe, nontoxic, and well tolerated.[4]

In the survival arm, the average duration of Selected Vegetables/Sun’s Soup treatment was 7.3 months (range, 4–17 months). The median survival time from diagnosis for the six patients who ingested Selected Vegetables/Sun’s Soup was 15.5 months (range, 8 to more than 24 months), compared with a median survival time from diagnosis of 4 months (range, 1–12 months) for the 13 patients in the control group. This difference in median survival time was reported to be statistically significant.[4]

As in the toxicity arm, body weight and KPS were measured twice in the survival arm. Body-weight measurements were made at study entry and at an average of 4.8 months later (range, 3–7 months) for the six patients in the Selected Vegetables/Sun’s Soup treatment group. Among the 13 patients in the control group, nine had weight measurements made at study entry and at an average of 2.6 months later (range, 1–7 months); however, the second body-weight measurements were not available for four control subjects. The average percent body-weight loss for the six patients in the Selected Vegetables/Sun’s Soup treatment group was 2.1%; for the nine patients in the control group, the average percent body-weight loss was 11.6%. This 9.5% difference in body-weight loss was reported to be statistically significant. The two groups of patients had similar average body weights at study entry.[4]

KPS was measured at study entry and again 3 months later for all six patients in the Selected Vegetables/Sun’s Soup treatment group. For the 13 patients in the control group, KPS was measured at study entry and 1 to 3 months later. The first and second KPS scores did not differ substantially for the patients in the Selected Vegetables/Sun’s Soup treatment group. In fact, the second score was higher (indicating an improving condition) for five of the six patients; for the sixth patient, the first and second scores were the same. In contrast, the second KPS score was lower than the first (indicating a worsening condition) for all 13 patients in the control group. When the average KPS score at study entry for the control subjects was compared with the average score measured 1 to 3 months later, a statistically significant decline in KPS was noted. The average KPS score at study entry for the patients in the control group was not substantially different from the average KPS score at study entry for patients in the Selected Vegetables/Sun’s Soup treatment group.[4]

Although treatment with Selected Vegetables/Sun’s Soup was associated with substantial benefits in this trial, the results cannot be considered conclusive. Several major weaknesses in the design and execution of the trial could have affected the outcome. One major weakness is the small numbers of patients enrolled in the survival arm (six patients in the Selected Vegetables/Sun’s Soup treatment group and 13 in the control group). Larger numbers of patients are needed to obtain reliable results. Another weakness is that the patients in the survival arm were not randomly assigned to the treatment group and the control group. The treatment group consisted of individuals who agreed to be treated with Selected Vegetables/Sun’s Soup; those who refused treatment comprised the control group. It is possible there were important, unidentified differences between the patients who agreed to be treated with Selected Vegetables/Sun’s Soup and those who did not. Nonetheless, in view of the positive results of this trial, CAPCAM recommended that a randomized phase III trial of Selected Vegetables/Sun’s Soup be conducted in patients with non-small cell lung cancer.[3]

In 2001, the developer reported clinical findings for an additional 16 patients who had stage III or stage IV non-small cell lung cancer and who had been treated with Selected Vegetables/Sun’s Soup.[5] The formulation ingested by these patients was Frozen SV, or FSV.[5,6] Among the 16 patients, 12 consumed FSV for a period of 2 months or more and were considered eligible for analysis. The duration of FSV treatment for these 12 patients ranged from 5 months to more than 46 months. All of the patients were treated with conventional therapy (one or more of the following: surgery, radiation therapy, chemotherapy, or pleurodesis) in addition to treatment with Selected Vegetables/Sun’s Soup.

Among these 12 patients, two had no residual tumor after surgery to remove the primary tumor (n = 1) or surgery to remove the primary tumor and a contralateral lymph node metastasis (n = 1). The patient with the lymph node metastasis consumed FSV for more than 32 months and remained tumor free more than 30 months. This patient survived more than 33 months. The other patient ingested FSV for 14 months and survived 20 months. No information was available concerning the tumor-free period for this second patient.

Among the ten remaining eligible patients, two were reported to have had a complete response to therapy. One of the patients had surgery to remove the primary tumor and then chemotherapy, radiation therapy, and FSV therapy to treat pleural effusion. This patient ingested FSV for 5 months and was still alive at the end of the study period (more than 8 months later). The other patient had surgery to remove the primary tumor, and then radiation therapy and FSV therapy to treat brain and bone metastases. This patient consumed FSV for 16 months and survived 22 months. No information was available about the duration of the tumor-free period for the remaining patient.

Among the eight remaining eligible patients, three had a partial response to treatment, and four had stable or progressive disease. Tumor response data were not available for one eligible patient.

Overall, the median survival time for the 12 eligible patients was 33.5 months, which is substantially longer than the median survival times cited by the developer for historical control subjects (range, 4–15 months).[5] Furthermore, the KPS score, which was measured at the start of FSV treatment and again 5 or more months later, improved for all but one of the eligible patients. On average, the second KPS score was 63% higher than the first score.[5]

As in the case of the phase I/II trial, the results of this nonconsecutive case series should be viewed with caution. Once again, a number of major weaknesses in the design of this clinical study could have influenced its outcome. Among these weaknesses are the following:

• The study included only a small number of patients.
• The survival analysis relied on comparisons with historical control subjects rather than an actual control group.
• All of the patients in the study were aware of the reported benefits of Selected Vegetables/Sun’s Soup and had actively sought treatment with it.

With respect to the third point, it is important to note that results obtained with such highly motivated, self-selected patients might not be typical of those obtained with most patients diagnosed with advanced non-small cell lung cancer.

The developer is currently conducting a phase II clinical trial to determine whether Selected Vegetables/Sun’s Soup can improve immune system function in patients with AIDS.[6] No information is available about the number of patients enrolled in this trial, and preliminary findings have been described for just one patient.

A randomized phase III trial (SFC-SV002 ¹³) of patients with stage IIIB or stage IV non-small cell lung cancer is being conducted. The primary objective is to compare the survival of patients receiving Selected Vegetables (SV) Sun's Soup dietary supplement with those receiving a placebo while undergoing treatment with best supportive care (i.e., radiation therapy, surgery, or palliative care).

References

1. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. ⁶ Last accessed November 28, 2007. 
   
   
2. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. ⁷ Last accessed November 28, 2007. 
   
   
3. Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM).: Minutes of the First Meeting - July 8-9, 1999: Section X: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement - Dr. Alexander Sun, Medical Director, Connecticut Institute of Aging and Cancer. Bethesda, Md: National Center for Complementary and Alternative Medicine, 2002. Available online. ⁸ Last accessed November 28, 2007. 
   
   
4. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
   
   
5. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   
6. Sun Farm Vegetable Soup (SV). Milford, Conn: Sun Farm Corporation, 2000. Available online. ⁹ Last accessed November 28, 2007. 
   
   

Adverse Effects

The only reported adverse effect with the use of Selected Vegetables/Sun’s Soup was a feeling of fullness or bloatedness when DSV was consumed in the amount specified in the phase I/II clinical trial.[1] No adverse effects were reported after ingestion of FSV.[2]

References

1. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
   
   
2. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   

Level of Evidence for Selected Vegetables/Sun's Soup

Existing data supporting the effectiveness of Selected Vegetables/Sun’s Soup as a treatment for cancer are limited and weak. To date, only two clinical studies have been reported in the peer-reviewed scientific literature.[1,2] These studies tested the ability of Selected Vegetables/Sun’s Soup to prolong the survival of patients with advanced non-small cell lung cancer. Although ingestion of Selected Vegetables/Sun’s Soup was associated with improved survival in both studies, the results may not be reliable because of the small numbers of patients included in the studies (i.e., a total of 18 evaluable patients) and because of other major weaknesses in the designs of the studies. Different formulations of Selected Vegetables/Sun’s Soup were used in the two studies, making a comparison of the results difficult. Information about the effectiveness of Selected Vegetables/Sun’s Soup as a treatment for other types of cancer is found only in anecdotal reports,[3,4] and no information is available about the safety or the efficacy of this treatment approach in pediatric patients. Additional larger, well-designed clinical studies that test identical formulations of vegetables and herbs are necessary to determine more clearly whether Selected Vegetables/Sun’s Soup can be useful in the treatment of non-small cell lung and other types of cancer.

Separate levels of evidence scores are assigned to qualifying human studies on the basis of statistical strength of the study design and scientific strength of the treatment outcomes (i.e., endpoints) measured. The resulting two scores are then combined to produce an overall score. For additional information about levels of evidence analysis, refer to Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine ².

References

1. Sun AS, Ostadal O, Ryznar V, et al.: Phase I/II study of stage III and IV non-small cell lung cancer patients taking a specific dietary supplement. Nutr Cancer 34 (1): 62-9, 1999.  [PUBMED Abstract]
   
   
2. Sun AS, Yeh HC, Wang LH, et al.: Pilot study of a specific dietary supplement in tumor-bearing mice and in stage IIIB and IV non-small cell lung cancer patients. Nutr Cancer 39 (1): 85-95, 2001.  [PUBMED Abstract]
   
   
3. Sun AS: Herbal Treatment of Malignancy. US Patent 5437866. August 1, 1995. Washington, DC: US Patent and Trademark Office, 1995. Available online. ⁶ Last accessed November 28, 2007. 
   
   
4. Sun A: Food therapy for non-small cell lung cancer. In: Comprehensive Cancer Care: Integrating Complementary and Alternative Therapies - A Conference for Health professionals, June 12-14, 1998. Breakout Session 405: Herbal Therapies. Available online. ⁷ Last accessed November 28, 2007. 
   
   

Changes to This Summary (01/31/2008)

The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Editorial changes were made to this summary.

More Information

Additional Information about CAM Therapies

• The National Center for Complementary and Alternative Medicine ¹⁵ (NCCAM).
• The National Cancer Institute Office of Cancer Complementary and Alternative Medicine ¹⁶ (OCCAM).
• CAM on PubMed ¹⁷, a special subset of the PubMed scientific literature database created through a partnership between NCCAM and the National Library of Medicine.

About PDQ

• PDQ® - NCI's Comprehensive Cancer Database ¹⁸

  Full description of the NCI PDQ database.

Other PDQ Summaries

• PDQ® Cancer Information Summaries: Adult Treatment ¹⁹

  Treatment options for adult cancers.

• PDQ® Cancer Information Summaries: Pediatric Treatment ²⁰

  Treatment options for childhood cancers.

• PDQ® Cancer Information Summaries: Supportive and Palliative Care ²¹

  Side effects of cancer treatment, management of cancer-related complications and pain, and psychosocial concerns.

• PDQ® Cancer Information Summaries: Screening/Detection (Testing for Cancer) ²²

  Tests or procedures that detect specific types of cancer.

• PDQ® Cancer Information Summaries: Prevention ²³

  Risk factors and methods to increase chances of preventing specific types of cancer.

• PDQ® Cancer Information Summaries: Genetics ²⁴

  Genetics of specific cancers and inherited cancer syndromes, and ethical, legal, and social concerns.

• PDQ® Cancer Information Summaries: Complementary and Alternative Medicine ²⁵

  Information about complementary and alternative forms of treatment for patients with cancer.

Important:

This information is intended mainly for use by doctors and other health care professionals. If you have questions about this topic, you can ask your doctor, or call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

Glossary Terms

A disease caused by human immunodeficiency virus (HIV). People with acquired immunodeficiency syndrome are at an increased risk for developing certain cancers and for infections that usually occur only in individuals with a weak immune system. Also called AIDS.

Cancer that begins in cells that line certain internal organs and that have gland-like (secretory) properties.

Another treatment used together with the primary treatment. Its purpose is to assist the primary treatment. Also called adjunct therapy.

A small gland that makes steroid hormones, adrenaline, and noradrenaline. These hormones help control heart rate, blood pressure, and other important body functions. There are two adrenal glands, one on top of each kidney. Also called suprarenal gland.

An unwanted side effect of treatment.

A disease caused by the human immunodeficiency virus (HIV). People with AIDS are at an increased risk for developing certain cancers and for infections that usually occur only in individuals with a weak immune system. Also called acquired immunodeficiency syndrome.

An incomplete description of the medical and treatment history of one or more patients. Anecdotal reports may be published in places other than peer-reviewed, scientific journals.

The root of any of a group of herbs called Angelica. It has been used in some cultures to treat certain medical problems, including gastrointestinal problems such as loss of appetite, feelings of fullness, and gas.

A substance found in soybeans that may slow down or stop the spread of cancer. This substance does not break down in an autoclave (a device that uses steam under high pressure to sterilize medical and laboratory supplies and equipment).

A type of polysaccharide (string of sugar molecules) obtained from several types of mushrooms. It is being studied as a treatment for cancer and as an immune system stimulant.

The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance that is taken by mouth can be absorbed and used by the body.

An isoflavone found in soy products. Soy isoflavones (estrogen-like substances made by some plants) are being studied to see if they help prevent cancer.

Glandular organ located on the chest. The breast is made up of connective tissue, fat, and breast tissue that contains the glands that can make milk. Also called mammary gland.

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

A case in which cancer cells are found in the body, but the place where the cells first started growing (the origin or primary site) cannot be determined. Also called carcinoma of unknown primary and CUP.

Cancer that begins in the skin or in tissues that line or cover internal organs.

The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.

Treatment with drugs that kill cancer cells.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The longest part of the large intestine, which is a tube-like organ connected to the small intestine at one end and the anus at the other. The colon removes water and some nutrients and electrolytes from partially digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus.

Having to do with the colon or the rectum.

Forms of treatment that are used in addition to (complementary) or instead of (alternative) standard treatments. These practices generally are not considered standard medical approaches. Standard treatments go through a long and careful research process to prove they are safe and effective, but less is known about most types of CAM. CAM may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation. Also called CAM.

The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

A treatment that is given at the same time as another.

Having to do with the opposite side of the body.

In a clinical trial, the group that does not receive the new treatment being studied. This group is compared to the group that receives the new treatment, to see if the new treatment works.

A currently accepted and widely used treatment for a certain type of disease, based on the results of past research. Also called conventional treatment.

An estrogen-like substance (phytoestrogen) made by some plants. Coumestans may have anticancer effects.

A type of coumestan. Coumestans are estrogen-like substances (phytoestrogens) made by some plants. Coumestans may have anticancer effects.

An isoflavone found in soy products. Soy isoflavones are being studied in the prevention of cancer.

A product that is added to the diet. A dietary supplement is taken by mouth, and usually contains one or more dietary ingredient (such as vitamin, mineral, herb, amino acid, and enzyme). Also called nutritional supplement.

The amount of medicine taken, or radiation given, at one time.

Effectiveness. In medicine, the ability of an intervention (for example, a drug or surgery) to produce the desired beneficial effect.

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

Patients whose response to a treatment can be measured because enough information has been collected.

A method used to dry substances, such as food, to make them last longer. The substance is frozen and then dried in a vacuum.

Having to do with the stomach.

An isoflavone found in soy products. Soy isoflavones are being studied to see if they help prevent cancer.

An herb with a root that has been used in some cultures to treat certain medical problems. It may have anticancer effects.

A unit of weight in the metric system. One gram is equal to one thousandth of a kilogram and is approximately 30-times less than an ounce.

The fruit of the hawthorn tree or bush. It has been used in some cultures to treat certain medical problems, including heart problems and gastrointestinal problems.

An herb used in traditional Chinese medicine to treat certain medical problems. It has been used to boost the immune system and may have anticancer effects.

An individual treated in the past and used in a comparison group when researchers analyze the results of a clinical study that had no control group. The use of a control, or comparison, group helps researchers determine the effects of a new treatment more accurately.

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormonal therapy, and hormone treatment.

The complex group of organs and cells that defends the body against infections and other diseases.

Taking into the body by mouth.

Use of a syringe and needle to push fluids or drugs into the body; often called a "shot."

A substance found in many foods that come from plants, including corn, wheat, rice, and soybeans, and in large amounts in cereals and legumes. It is being studied in the prevention of cancer. Also called IP6 and phytic acid.

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called I.V..

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

An estrogen-like substance made by some plants, including the soy plant. Soy isoflavones are being studied in the prevention of cancer, hot flashes that occur with menopause, and osteoporosis (loss of bone density).

A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. KPS may be used to determine a patient's prognosis, to measure changes in a patient’s ability to function, or to decide if a patient could be included in a clinical trial. Also called KPS.

Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.

A complex molecule that has both protein and sugars. Lectins are able to bind to the outside of a cell and cause biochemical changes in it. Lectins are made by both animals and plants.

A malignant (cancerous) tumor of smooth muscle cells that can arise almost anywhere in the body, but is most common in the uterus, abdomen, or pelvis.

A beta-glucan (a type of polysaccharide) from the mushroom Lentinus edodes (shiitake mushroom). It has been studied in Japan as a treatment for cancer.

A ranking system used to describe the strength of the results measured in a clinical trial or research study. The design of the study (such as a case report for an individual patient or a randomized double-blinded controlled clinical trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence.

A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.

One of a pair of organs in the chest that supplies the body with oxygen, and removes carbon dioxide from the body.

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

Cancerous. Malignant tumors can invade and destroy nearby tissue and spread to other parts of the body.

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is.

The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).

Having to do with metastasis, which is the spread of cancer from one part of the body to another.

The sum of the atomic masses of all atoms in a molecule, based on a scale in which the atomic masses of hydrogen, carbon, nitrogen, and oxygen are 1, 12, 14, and 16, respectively. For example, the molecular mass of water, which has two atoms of hydrogen and one atom of oxygen, is 18 (i.e., 2 + 16).

The smallest particle of a substance that has all of the physical and chemical properties of that substance. Molecules are made up of one or more atoms. If they contain more than one atom, the atoms can be the same (an oxygen molecule has two oxygen atoms) or different (a water molecule has two hydrogen atoms and one oxygen atom). Biological molecules, such as proteins and DNA, can be made up of many thousands of atoms.

A type of bean grown in warm climates, usually for its seed and for bean sprouts. Mung bean may have anticancer effects.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.

A clinical study that includes some, but not all, of the eligible patients identified by the researchers during the study registration period. This type of study does not usually have a control group.

Not harmful or destructive.

By or having to do with the mouth.

A measure of weight (one-sixteenth pound) and volume (one-eighth cup).

Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of palliative care is to prevent or treat as early as possible the symptoms of a disease, side effects caused by treatment of a disease, and psychological, social, and spiritual problems related to a disease or its treatment. Also called comfort care, supportive care, and symptom management.

A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.

PDQ is an online database developed and maintained by the National Cancer Institute. Designed to make the most current, credible, and accurate cancer information available to health professionals and the public, PDQ contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, complementary and alternative medicine, and supportive care; a registry of cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. Most of this information, and more specific information about PDQ, can be found on the NCI's Web site at http://www.cancer.gov/cancertopics/pdq. Also called Physician Data Query.

A trial to study the safety, dosage levels, and response to a new treatment.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A plant-based compound that can compete with dietary cholesterol to be absorbed by the intestines, resulting in lower blood cholesterol levels. Plant sterols may have some effect in cancer prevention. Also called phytosterol.

An abnormal collection of fluid between the thin layers of tissue (pleura) lining the lung and the wall of the chest cavity.

A medical procedure that uses chemicals or drugs to cause inflammation and adhesion between the layers of the pleura (a thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). This prevents the buildup of fluid in the pleural cavity. It is used as a treatment for severe pleural effusion.

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary endpoint will be is decided before the study begins.

Cancer that is growing, spreading, or getting worse.

A gland in the male reproductive system. The prostate surrounds the part of the urethra (the tube that empties the bladder) just below the bladder, and produces a fluid that forms part of the semen.

A compound that interferes with the ability of certain enzymes to break down proteins. Some protease inhibitors can keep a virus from making copies of itself (for example, AIDS virus protease inhibitors), and some can prevent cancer cells from spreading.

The overall enjoyment of life. Many clinical trials assess the effects of cancer and its treatment on the quality of life. These studies measure aspects of an individual’s sense of well-being and ability to carry out various activities.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

When referring to an experiment or clinical trial, the process by which animal or human subjects are assigned by chance to separate groups that compare different treatments or other interventions. Randomization gives each participant an equal chance of being assigned to any of the groups.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.

The fruit of the jujube plant. It has been used in some cultures to treat certain medical problems.

A decrease in the size of a tumor or in the extent of cancer in the body.

Cancer cells that remain after attempts to remove the cancer have been made.

In medicine, an improvement related to treatment.

A substance found in soybeans and many other plants. Saponins may help lower cholesterol and may have anticancer effects.

A cancer of the bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.

A person who has studied science, especially one who is active in a particular field of investigation.

An herb that belongs to a group of herbs named the Scutellaria species or scullcap. Both the root and the above-ground part have been used to make herbal medicines. The root has been used in traditional Chinese medicine to treat lung cancer and other medical problems.

The root of an herb called Polygala senega. It has been used in some cultures to treat certain medical problems, including problems of the respiratory system.

A dark oriental mushroom widely used as a food. Several anticancer substances have been found in shiitake mushrooms, including lentinan, which has been studied in Japan as a treatment for stomach and colorectal cancer. The scientific name is Lentinus edodes.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Stage I is divided into stages IA and IB. In stage IA, the tumor is in the lung only and is 3 centimeters or smaller. In stage IB, one or more of the following is true: (1) the tumor is larger than 3 centimeters; (2) cancer has spread to the main bronchus of the lung, and is at least 2 centimeters from the carina (where the trachea joins the bronchi); (3) cancer has spread to the innermost layer of the membrane that covers the lungs; and/or (4) the tumor partly blocks the bronchus or bronchioles and part of the lung has collapsed or developed pneumonitis (inflammation of the lung).

Stage III is divided into stages IIIA and IIIB. In stage IIIA, cancer has spread to lymph nodes on the same side of the chest as the tumor; the tumor may be any size and cancer may have spread to the main bronchus, the chest wall, the diaphragm, the pleura around the lungs, or the membrane around the heart, but cancer has not spread to the trachea; and part or all of the lung may have collapsed or developed pneumonitis (inflammation of the lung). In stage IIIB, the tumor may be any size and has spread to lymph nodes above the collarbone or in the opposite side of the chest from the tumor; AND/OR to any of the following places: the heart, major blood vessels that lead to or from the heart, the chest wall, the diaphragm, the trachea, the esophagus, the sternum (chest bone) or backbone, to more than one place in the same lobe of the lung, and/or into the fluid of the pleural cavity surrounding the lung.

Cancer has spread (1) beyond the layer of fatty tissue around the kidney and may be found in 1 nearby lymph node; or (2) to 2 or more nearby lymph nodes; or (3) to other organs, such as the bowel, pancreas, or lungs, and may be found in nearby lymph nodes. Also called stage IV renal cell cancer.

Cancer that may have spread to lymph nodes and has spread to another lobe of the lungs or to other parts of the body, such as the brain, liver, adrenal glands, kidneys, or bone.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

Beneath the skin.

Care given to improve the quality of life of patients who have a serious or life-threatening disease. The goal of supportive care is to prevent or treat as early as possible the symptoms of a disease, side effects caused by treatment of a disease, and psychological, social, and spiritual problems related to a disease or its treatment. Also called comfort care, palliative care, and symptom management.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancerous), or malignant (cancerous). Also called neoplasm.

Cells, tissues, or animals used to study the development and progression of cancer, and to test new treatments before they are given to humans. Animals with transplanted human tumors or other tissues are called xenograft models.