Study 1: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Chemotherapy: A Randomized Double Blind Placebo Controlled Study; Study 2: Effects of a Dietary Supplement (SV) on Advanced NSCLC Treated With Best Supportive Care: A Randomized Double Blind Placebo Controlled Study
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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Median Survival Time (MST)
Henry S Sacks, MD, Ph.D
Mount Sinai School of Medicine
United States: Food and Drug Administration
SV-001 and SV-002
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