The primary objective of these two studies is to test the hypothesis that the daily
ingestion of a dietary supplement, Selected Vegetables and Herbs Mix (SV), which consists
of non-toxic botanicals containing known anti-cancer and/or immune enhancing components,
may prolong the survival time of stage IIIB/IV non-small cell lung cancer (NSCLC)
patients. Either SV or placebo will be added to their daily diet in a double-blind
randomized fashion, so that there will be 2 chances out of 3 of receiving SV and 1 chance
out of 3 of receiving placebo.
- Study 1: For newly diagnosed patients who will be receiving or have received less
than 4 weeks of, a standard chemotherapy regimen.
- Study 2: For those who have stopped or refuse standard chemotherapy but will receive
best supportive care.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00246727.
Carcinoma of the lung is the leading cause of cancer related deaths in North America.
Non-small Cell Lung Cancer (NSCLC) causes the death of more than 400,000 patients
annually in the US and Western Europe. The benefit of conventional therapies, such as
chemotherapy and radiotherapy, for unresectable stage IIIB and IV NSCLC patients is
small; the generally accepted median survival time of late stage patients has remained
4-6 months in the "Supportive Care" group and 6-9 months in the chemotherapy treatment
group; the one-year survival is about 20%. Ideal Treatment for NSCLC: The toxicity of
chemotherapy and side-effects of radiotherapy to the quality of life of the patients have
been a major issue in cancer treatments. It has been significant enough that many
patients choose to forgo standard treatments. Furthermore, the current chemotherapy for
advanced NSCLC is quite expensive, about $50,000 to $100,000 per year. Therefore, an
ideal treatment for advanced NSCLC patients should meet the following criteria:
1. Prolong patient survival.
2. Minimal toxicity.
3. Improvement in the patient's quality of life.
4. Relatively inexpensive. A phytomix consisting of selected vegetables and herbs
appears to meet all these criteria. The phytomix consists of 19 vegetable and herbs
in a highly concentrated form. These vegetables and herbs were selected based on
their anti-cancer and immune-enhancing activities. Each batch of raw materials has
gone through a very strict quality control (QC) scheme to make sure the product
meets our QC standards and devoid of deleterious contaminations, such as heavy
metals, pesticides, aflatoxin, and microorganisms. The manufacturing process is
tightly controlled to ensure batch-to-batch consistency. The final product, a 20
gram freeze-dried powder, is sealed in a pouch. In our previous studies, patients
who ingested phytomix daily for 17-60 months showed no clinical sign of adverse
effect.
The Objectives of the proposed studies are to evaluate the benefits and adverse reactions
of adding SV to the daily diet of cancer patients who are willing to undergo the
chemotherapy (Study 1) or those who refuse chemotherapy (Study 2).
Lead OrganizationSun Farm Corporation
