WHEAT BRAN FIBER EFFECT ON COLONIC ADENOMATOUS POLYP RECURRENCE

关于饮食中的潜在作用， 纤维在预防结直肠癌。 动物的结果 研究、人类流行病学研究和作用机制评价 表明麦麸纤维摄入量与大 肠癌发病率 最近，在一项试点研究中， 亚利桑那州癌症中心报告说，补充13.5克/天的 麦麸纤维8周（安慰剂导入期4周后） 显著降低（p <.001）隐窝器官中的[3 H]-胸苷标记 和24小时的直肠活检培养物， 手术切除的结直肠癌 1987年10月， 最近启动了一项随机II期试验（NCI #PO1 CA 41108）， 切除的结直肠腺瘤患者比较麦麸纤维（13.5）， 钙（1500毫克）和麦麸纤维加钙的组合 与安慰剂（2.0克麦麸纤维和250 mg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[3 H]-胸苷标记 未受影响的扁平粘膜活检组织的隐窝和24小时生长培养物 样品，和（2）降低粪便胆汁酸浓度，特别是 去氧胆酸。 这项II期随机试验实现了全面 1989年2月患者增加。 因为有100个病人 需要，有必要在8月1日之前再招募5名患者， 1989. 1990年6月将完成并进行最后分析。 的 拟议的第三期试验将于一九九零年七月展开。 因为 似乎没有证据表明纤维毒性在9个月期间， 在正在进行的II期试验中，我们计划评估纤维（与安慰剂相比）， 950例腺瘤复发的有效干预 两组III期临床试验中的患者。 次要分析 在250例腺瘤患者的亚组中进行的III期试验的终点将 包括评价干预对[3 H]-胸苷的影响 在隐窝器官中进行标记，在直肠粘膜中进行24小时生长培养 活检样本 本文概述了该项目的背景、意义、目标、 III期腺瘤性息肉复发试验 包括麦麸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.