This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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 marginal;the generally accepted median survival time (MST) of stage IV patients has remained 4-6 months in the """"""""Supportive Care"""""""" group and 6-9 months in the treatment group;the one-year survival is about 20%. National Cancer Institute (NCI) quoted in its Web page a meta-analysis of 52 randomized clinical trials that showed an absolute survival benefit of 4% at 2 years with chemotherapy and/or radiotherapy. A recent paper and an Editorial comment of New Engl J Med concluded that 4 widely used chemotherapy regimens offer only marginal benefits with severe toxicities for advanced NSCLC patients and """"""""It is time to move on from chemotherapy. Because of the poor overall results, NCI concludes that More Effective Treatments for NSCLC Are Urgently Needed. SV is a dietary supplement consisting of selected botanicals and herbs chosen for their scientifically documented immune-potentiating, anticancer, or antiviral activity. Preliminary data have shown that daily ingestion of SV can prolong the median survival time 3-fold over the control group of advanced non-small cell lung cancer (NSCLC) patients. This is a randomized, placebo-controlled, double-blind study designed to determine if adding a dietary supplement, (SV) to a standard chemotherapy regimen in patients with Stage IIIB/IV NSCLC will prolong survival. Information about the effects of the addition of SV on tumor response, toxicities and quality of life will also be collected and analyzed.
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