(Scanned from the applicants description) The American Cancer Society estimates 564,800 Americans will die of cancer this year. Evidence suggests that up to one-third of those deaths are related to malnutrition and cachexia for which there are currently no effective nutritional interventions. Weight loss is a predictor of survival in patients receiving cancer therapy and supplemental nutrition is often indicated in patients undergoing surgery, chemotherapy, or radiation therapy. Phase I research has clearly shown that daily supplementation with HMB/Arg/Gln was effective in preventing and reversing the weight and muscle mass losses in stage IV cancer patients who were undergoing various regimens of chemotherapy. In this Phase II multicenter trial, it is proposed to include a more homogenous group of cancer patients, with diagnoses limited to lung and proximal GI-tract cancers which are notoriously known to result in significant wasting. The proposal will determine if early therapeutic interventions with HMB/Arg/Gln will result in (a) decreasing weight loss, (b) reversing muscle wasting, (c) decreasing protein turnover, (d) decreasing toxicity to chemotherapeutic agents and better adherence to chemotherapeutic regimens, and (e) improving overall feeling of well being. If as expected Phase II results confirm the effectiveness of the nutrient mixture in cancer patients, a product would be marketed for this purpose.
Since over 1.2 million cases of cancer are expected to be diagnosed this year alone (American Cancer Society), the market potential for the proposed nutritional product is very large. It is expected that Phase II will continue to support the positive findings of Phase I and that a product containing the nutrient combination in a ready-to-drink formulation would be marketed upon this confirmation. A balanced nutritional product containing high quality protein and other nutrients would likely be developed. It is envisioned that these products will be highly effective over-the-counter and/or prescription nutritional supplements for cancer patients with cachexia to improve quality of life of cancer patients.
