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.

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.