title: Study of Prevention of Colorectal Cancer through Lifestyle Modification: an Introduction to the Protocol.
abstract: Previous epidemiological studies have suggested that lack of exercise and a high fat diet increase the risk of colorectal cancer. We planned a clinical trial to test these propositions, using subjects with multiple colorectal adenomas and/or carcinomas. Enrolment in this study was conducted in two stages. First, patients were invited to participate in the dietary modification part of the study. Those agreeing to participate were given dietary advice, and 3 months later all subjects to whom the exercise exclusion criteria do not apply were invited to participate in the exercise part of the study. The subjects were randomized to two groups. A total of two hundred and eleven patients meeting the entry criteria have been invited to join the trial, of whom 165 (78%) consented to participate in the dietary modification part of the study. After excluding those unsuitable according to the exclusion criteria for the exercise regimen, the remaining 124 subjects were further invited to participate in the exercise regimen part of the study. One hundred and three (83%) subjects have given their consent. Obtaining informed consent in two stages and the free provision of lifestyle modification measures were factors that contributed to this favorable participation rate.
authors.affiliation: Department of Cancer Epidemiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka 537-8511, Japan. cancer@gol.com
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