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Japanese Journal of Clinical Oncology Advance Access published online on January 17, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym134
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Randomized Phase II Trial of Preoperative Exercise to Reduce Operative Risk in Gastric Cancer Patients with Metabolic Syndrome: Adjuvant Exercise for General Elective Surgery (AEGES) Study Group

Haruhiko Cho1,, Akira Tsuburaya1, Junichi Sakamoto2, Satoshi Morita2, Koji Oba3, Takaki Yoshikawa1 and Naomi Miyajima1

1 Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama
2 Medical Administration Course of Master's Degree Program, Nagoya University, Nagoya
3 EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan

For reprints and all correspondence: Haruhiko Cho, Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 1-1-2, Nakao, Asahi-ku, Yokohama 2410815, Japan. E-mail: choharuhiko{at}kcch.jp

Received May 18, 2007; accepted September 16, 2007

This study is conducted to evaluate the efficacy and safety of preoperative exercise in patients with T1N0/T1N1/T2N0 gastric cancer and metabolic syndrome, which has emerged as a global health care issue. The primary endpoint is an incidence of perioperative complications and the secondary endpoints are weight change, change in high density lipoprotein cholesterol, operation time, intraoperative blood loss, number of dissected lymph nodes. The sample size is 86 (43 for surgery alone and 43 for exercise group) to select promising treatment for Phase III trial in a randomized Phase II setting.

Key Words: preoperative exercise • gastric cancer • metabolic syndrome


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