Wine for Cancer-Associated Anorexia

描述（由申请人提供）：癌症相关厌食症或食欲不振，发生在>80%的晚期不可治愈癌症患者中。它是癌症患者最令人不安的三大症状之一，也是早期死亡的有力预测因素。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，甲地孕酮醋酸酯是最好的药物之一，可用于缓解厌食症，但它改善食欲的患者不到40%。葡萄酒可以改善醋酸甲地孕酮的益处吗？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，世界各地的主要癌症组织-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，尽管这一建议的广泛性，但迄今为止还没有研究在癌症相关厌食症患者中测试葡萄酒。基于上述，我们提出了一项194例患者的临床试验，以确定葡萄酒是否可以改善醋酸甲地孕酮的益处。这项试验将作为以下三个目标的焦点：1。确定葡萄酒加醋酸甲地孕酮联合治疗癌症相关性厌食症患者是否比醋酸甲地孕酮单用更能改善食欲。2.总结并比较葡萄酒加醋酸甲地孕酮与醋酸甲地孕酮单药治疗相关的不良事件。3.探讨葡萄酒与醋酸甲地孕酮合用是否会改变调节食欲的激素环境。我们将专门寻找循环中瘦素、生长激素释放肽和神经肽y的改变。

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.