Wine for Cancer-Associated Anorexia

描述(申请人提供)：癌症相关的厌食症，或食欲不振，发生在80%的晚期不治之癌患者。它是癌症患者最令人担忧的三大症状之一，也是早期死亡的有力预测因素。但治标不治本的选择仍然有限。我们小组已经证明，醋酸甲地孕酮是缓解厌食症的最佳药物之一，但它改善食欲的患者不到40%。葡萄酒能改善甲地孕酮的益处吗？我们假设它是可以的。过多的流行病学和营养学研究指出，葡萄酒消费与体重和/或卡路里摄入量增加之间存在直接关系。此外，世界各地的主要癌症组织--包括美国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以下建议：“经医生批准，喝一杯葡萄酒。”值得注意的是，尽管有这些令人信服的研究，尽管这项建议具有广泛的性质，但到目前为止，还没有研究测试葡萄酒在癌症相关厌食症患者中的作用。在此基础上，我们提出了一项有194名患者参加的临床试验，以确定葡萄酒是否能改善甲地孕酮的益处。这项试验将作为以下三个目标的焦点：1.确定葡萄酒和甲地孕酮联合使用是否比单独使用甲地孕酮更好地改善癌症相关厌食症患者的食欲。2.总结和比较葡萄酒加甲地孕酮与单用甲地孕酮的不良反应。3.探索葡萄酒与甲地孕酮联合使用是否会改变调节食欲的荷尔蒙环境。我们将专门寻找循环中瘦素、Ghrelin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.