DESCRIPTION (provided by applicant): Cancer-associated anorexia, or loss of appetite, occurs in >80% of patients with advanced incurable cancer. It is one of the top three most troubling symptoms for cancer patients, and it is a strong predictor of early demise. Yet palliative options remain limited. Our group has demonstrated that megestrol acetate is one of the best agents available for palliating anorexia, but it improves appetite in fewer than 40% of patients. Can wine improve on the benefits of megestrol acetate? We hypothesize that it can. A plethora of epidemiological and nutritional studies point to a direct relationship between wine consumption and increased weight and/or caloric intake. Moreover, major cancer organizations throughout the world -including the National Cancer institute and American Society of Clinical - make the following recommendation to cancer patients with anorexia: "With your doctor's approval, drink a glass of wine." It is important to note that despite these compelling studies and despite the widespread nature of this recommendation, no study to date has tested wine in patients with cancer-associated anorexia. Base on the above, we propose a 194-patient clinical trial to determine whether wine can improve on the benefits of megestrol acetate. This trial will serve as the focal point for the following three aims: 1. To determine whether the combination of wine plus megestrol acetate improves appetite better than megestrol acetate alone in patients with cancer-associated anorexia. 2. To summarize and compare the adverse events associated with wine plus megestrol acetate versus megestrol acetate alone. 3. To explore whether wine in combination with megestrol acetate alters the hormonal milieu that modulates appetite. We will specifically look for alterations of circulating leptin, ghrelin, and neuropeptide y.
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