SKIN CANCER PROPHYLAXIS BY LOW FAT DIETARY INTERVENTION

通过低脂饮食干预预防皮肤癌

• 批准号: 2414165
• 负责人: HOMER Selton BLACK
• 金额: $ 9.94万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-04-19 至 1999-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2414165
• 关键词: basal cell carcinoma; basosquamous cell carcinoma; biopsy; cancer prevention; carcinogenesis; clinical research; diet therapy; dietary lipid; human subject; longitudinal human study; neoplasm /cancer epidemiology; neoplasm /cancer nutrition therapy; neoplasm /cancer relapse /recurrence; nutrition related neoplasm /cancer; nutrition related tag; skin neoplasms; therapy compliance

Experimental studies suggest that both quantity and quality of dietary lipid can influence the developmental course of several major forms of cancer -- notably skin, mammae, and intestine. For some cancers, epidemiological data support these studies and demonstrate a positive correlation between dietary fat intake and mortality rates. Until the current clinical trial, the relationship of diet to skin cancer had received little attention. The specific aim of this proposal is to provide definitive and statistically sound evidence, in a close-controlled clinical setting, as to the ability of a low-fat dietary intervention to alter the course of non-melanoma skin cancer development. 70 skin cancer patients presenting with a non-melanoma skin cancer (basal or squamous cell carcinoma), but having had not more than two previous ones, will undergo a series of laboratory and base-line evaluations. Upon qualification, the 70 patients will be randomized into two groups of 35 each. One group will be in a control in which no changes in dietary habits will be introduced. The remaining group (Dietary Intervention, DI) will adopt a diet characterized by reduced fat intake (20% of total caloric intake). Both groups will be examined at 4 months intervals, over 24 months, for non-melanoma skin cancer occurrence. In addition, the DI group will be evaluated monthly for dietary compliance and reinforced with respect to dietary goals. Laboratory tests will be completed at designated intervals to detect any adverse side-effects of the low-fat diet. Based upon data obtained from 116 patients completing the ongoing study, power calculations indicate that an additional 70 patients will provide significant (P<0.01) evidence with statistical probability of 80% that a low-fat diet reduces non-melanoma skin cancer incidence. The additional patients will provide not only definitive evidence for the involvement of dietary lipids in skin cancinogenesis, but will avail an effective means for the prevention and management of this highly prevalent form of cancer.

实验研究表明饮食的数量和质量 脂质可以影响几种主要形式的发展过程 癌症 - 特别是皮肤，哺乳动物和肠道。 对于某些癌症， 流行病学数据支持这些研究，并证明了阳性 饮食脂肪摄入与死亡率之间的相关性。 直到 当前的临床试验，饮食与皮肤癌的关系已有 很少受到关注。 该提议的具体目的是 在密切控制的 临床环境，关于低脂饮食干预的能力 改变非黑色素瘤皮肤癌发展的过程。 70皮肤癌 出现非黑色素瘤皮肤癌的患者（基底或鳞状 细胞癌），但以前不超过两个，将 接受一系列实验室和基线评估。 之上 资格，这70名患者将被随机分为两组35例 每个。 一组将受到控制，其中没有饮食的变化 将引入习惯。 其余组（饮食干预，DI） 将采用以减少脂肪摄入的特征的饮食（总计20％ 热量摄入）。 两组将在4个月间隔进行检查， 24个月，对于非黑色素瘤皮肤癌的发生。 另外，DI 小组将每月评估饮食合规性，并加强 尊重饮食目标。 实验室测试将在 指定的间隔以检测低脂的任何不良副作用 饮食。 基于从116名患者获得的数据，完成了正在进行的 研究，功率计算表明，另外70名患者将 提供统计概率为80％的显着（p <0.01）证据 低脂饮食会降低非黑色素瘤皮肤癌的发病率。 这 其他患者不仅会提供明确的证据 饮食脂质参与皮肤消除术，但会使用 预防和管理这种高度普遍的手段 癌症的形式。