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Japanese Journal of Clinical Oncology 32:550-553 (2002)
© 2002 Foundation for Promotion of Cancer Research

Rationale and Study Design of Dietary Intervention in Patients Polypectomized for Tumors of the Colorectum

Shinkan Tokudome1, Yoshifumi Yokoyama2, Takeshi Kamiya3, Kyoji Seno2, Harumi Okuyama4, Kiyonori Kuriki1, Jinglei Cheng1, Takaaki Nakamura5, Toshiko Fujii1, Hiromitsu Ichikawa1 and Makoto Itoh2,+

Departments of 1 Health Promotion and Preventive Medicine, 2 Internal Medicine and Bioregulation, 3 Internal Medicine and Pathophysiology and 5 Clinical Laboratory Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya and 4 Department of Preventive Nutraceutical Sciences, Nagoya City University Graduate School of Pharmaceutical Sciences, Nagoya, Japan

We have implemented a randomized controlled dietary intervention in patients polypectomized for tumors of the colorectum to elucidate potential beneficial effects of n-3 polyunsaturated fatty acids (PUFAs) on the development of colorectal tumors. Those individuals in the experimental group were advised not only to decrease their consumption of fats/oils as a whole and foods supplying n-6 PUFAs but also to increase intake of foods and supplements containing n-3 PUFAs, while those in the comparison group were cautioned to reduce intake of fats/oils as a whole. Patients’ compliance/adherence was monitored with a semi-quantitative food frequency questionnaire and by assessment of fatty acid concentrations in plasma, membranes of red blood cells and sigmoid colon samples. As for endpoints to assess tumor suppressive effects of n-3 PUFAs, the number/multiplicity, sizes and incidence rates of colorectal tumors were compared between the experimental and comparison groups after 12 and 24 months of the dietary intervention. On the specified assumption, the number of pairs needed for achieving statistical significance was calculated to be approximately 60–80. A randomized controlled trial is under way to secure enough patients, sustain compliance/adherence and minimize dropouts.

+ For reprints and all correspondence: Shinkan Tokudome, Department of Health Promotion and Disease Prevention, Nagoya City University Graduate School of Medical Sciences, Mizuho-ku, Nagoya 467-8601, Japan. E-mail: tokudome@med.nagoya-cu.ac.jp


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