Wine for Cancer-Associated Anorexia

描述（由申请人提供）：癌症相关的厌食症，或食欲不振，发生在80%的晚期无法治愈的癌症患者中。它是癌症患者最令人不安的三大症状之一，是早期死亡的有力预测指标。然而，治标不治本的选择仍然有限。我们的研究小组已经证明，醋酸甲地孕酮是缓解厌食症的最佳药物之一，但它能改善食欲的患者不到40%。葡萄酒能提高醋酸甲地孕酮的功效吗？我们假设它可以。大量的流行病学和营养学研究指出，葡萄酒消费与体重增加和/或热量摄入之间存在直接关系。此外，世界上主要的癌症组织——包括国家癌症研究所和美国临床学会——对患有厌食症的癌症患者提出了以下建议：“在医生的批准下，喝一杯葡萄酒。”值得注意的是，尽管有这些令人信服的研究，尽管这一建议具有广泛的性质，但迄今为止还没有研究在癌症相关性厌食症患者中测试葡萄酒。在此基础上，我们提出了一项194名患者的临床试验，以确定葡萄酒是否可以提高醋酸甲地孕酮的益处。这项试验将作为下列三个目标的焦点：确定葡萄酒加醋酸甲地孕酮是否比单用醋酸甲地孕酮更能改善癌症相关性厌食症患者的食欲。2. 总结和比较葡萄酒加醋酸甲孕酮与单独使用醋酸甲孕酮相关的不良事件。3. 探索葡萄酒与醋酸甲地孕酮结合是否会改变调节食欲的激素环境。我们将特别寻找循环瘦素、胃饥饿素和神经肽y的变化。

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.