WHEAT BRAN FIBER EFFECT ON COLONIC ADENOMATOUS POLYP RECURRENCE

关于饮食的潜在作用仍存在争议 纤维在预防结直肠癌中的作用。动物的结果 研究、人类流行病学研究和作用机制评价 提示小麦麸皮纤维摄入量与高摄入量之间呈负相关 肠癌发病率。最近，在一项试点研究中，美国国家航空航天局的调查人员 亚利桑那州癌症中心报告称，每天13.5克的补充剂 小麦麸皮纤维8周(经过4周的安慰剂磨合期) (p&lt；.001)[~3H]-胸腺嘧啶核苷在隐腺器官中的标记显著降低 取自患者的直肠活检组织进行24小时生长培养 与手术切除的结直肠癌有关。1987年10月，一位 随机第二阶段试验(NCI#PO1 CA41108)最近启动 切除的结直肠腺瘤患者比较小麦麸皮纤维(13.5)， 钙(1500毫克)和麦麸皮纤维加钙的组合 与安慰剂(2.0克小麦麸皮纤维和250毫克元素钙)相比 亚利桑那州太阳城。这项正在进行的试验的分析终点 包括：(1)抑制直肠粘膜中的[~3H]-胸腺嘧啶核苷标记 未受影响的扁平粘膜活检的隐窝和24小时生长培养 样本，以及(2)降低粪便胆汁酸浓度，特别是 脱氧胆酸。这项II期随机试验完全实现了 1989年2月病人应计费用。因为100名完全有空的病人 需要，需要在8月1日之前再招收5名患者， 1989年。完成和最后分析工作将于1990年6月进行。这个 拟议的第三阶段试验将于1990年7月开始。因为在那里 在9个月的时间里，似乎没有纤维毒性的证据 在正在进行的第二阶段试验中，我们计划评估纤维(与安慰剂相比)为 950年度预防腺瘤复发的有效干预措施 在拟议的双臂III期试验中的患者。二次分析 250名腺瘤患者的III期试验的终点将 包括对[~3H]-胸腺嘧啶核苷干预效果的评估 隐窝器官标记和直肠粘膜24小时生长培养 活组织检查样本。这份文件概述了背景、意义、目的 和第三期腺瘤性息肉复发试验的程序 将小麦麸皮纤维作为选择的试剂。

There is continuing controversy concerning the potential role of dietary fiber in the prevention of colorectal cancer. The results of animals studies, human epidemiologic studies and mechanism of action evaluations suggest an inverse relationship between wheat bran fiber intake and large bowel cancer incidence. Recently, in a pilot study, investigators at the Arizona Cancer Center have reported that a supplement of 13.5 gm/day of wheat bran fiber for 8 weeks (after 4 weeks of a placebo run-in period) significantly decreased (p <.001) [3H]-thymidine labeling in crypt organ and 24-hour outgrowth cultures of rectal biopsied obtained from patients with surgically resected colorectal cancers. In October, 1987, a randomized Phase II trial (NCI #PO1 CA41108) was initiated in recently resected colorectal adenoma patients comparing wheat bran fiber (13.5), calcium (1500 mg) and the combination of wheat bran fiber plus calcium versus placebo (2.0 grams wheat bran fiber and 250 mg elemental calcium) in Sun City, Arizona. The endpoints for analysis of this ongoing trial include: (1) inhibition of [3H]-thymidine labeling in rectal mucosal crypts and 24-hour outgrowth cultures of unaffected flat mucosal biopsy samples, and (2) lowering of fecal bile acid concentrations, specifically that of deoxycholic acid. This Phase II randomized trial achieved full patient accrual in February 1989. Because 100 fully available patients were needed, it was necessary to recruit 5 additional patients by August 1, 1989. Completion and final analysis will be performed in June 1990. The proposed Phase III trial will be initiated in July 1990. Because there appears to be no evidence of fiber toxicity during the 9 month period of the ongoing Phase II trial, we plan to evaluate fiber (versus placebo) as an effective intervention in the prevention of adenoma recurrence in 950 patients in the proposed two-armed Phase III trial. Secondary analysis endpoints for the Phase III trial in a subset of 250 adenoma patients will include the evaluation of the effect of the intervention on [3H]-thymidine labeling in crypt organ and 24-hour outgrowth cultures in rectal mucosal biopsy samples. This document outlines the background, significance, aims and procedures of the Phase III adenomatous polyp recurrence trial involving wheat bran fiber as the agent of choice.