The following information is summarized in a table ¹ 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 ² 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 ³ 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 ⁴) 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. ⁷ 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. ⁸ 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. ⁹ 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. ¹⁰ Last accessed November 28, 2007. 
   
   

Glossary Terms

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

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.