The following information is summarized in a table 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 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 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) 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. 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. 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. 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. Last accessed November 28, 2007. 
   
   

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