Exercise and Nutrition Prehabilitation Program During Preoperative Chemotherapy Followed by Esophagectomy in Older Patients With Esophageal Cancer: A Randomized Clinical Trial

ABSTRACT Background We conducted a single‐center randomized prospective phase 2 trial to investigate whether exercise alone or prehabilitation intervention, including exercise and nutrition, is effective in increasing skeletal muscle mass during neoadjuvant chemotherapy for elderly esophageal cancer patients. Methods Patients aged ≥ 60 years scheduled for preoperative chemotherapy followed by esophagectomy were randomized into three groups: Group A (no intervention), Group B (exercise‐only), and Group C (exercise plus nutritional intervention). Interventions occurred before treatment and surgery. The primary outcome was changes in skeletal muscle mass during chemotherapy. Results Among the 99 patients enrolled, 88 were analyzed: 31 in Group A, 26 in Group B, and 31 in Group C. The skeletal muscle mass decreased by 1.1% in Group A, increased by 0.9% in Group B, and increased by 1.7% in Group C. The change in skeletal muscle mass in Group C was significantly higher than that in Group A ( p = 0.013). The change in skeletal muscle mass in Group B tended to be higher than Group A, but the difference did not reach significance ( p = 0.140) Group C showed a greater increase in body weight, skeletal muscle mass index, and gait speed than Group A ( p = 0.014, p = 0.044, and p = 0.031, respectively). In Group B, skeletal muscle mass and skeletal muscle index tended to increase, but did not reach statistical significance compared to Group A ( p = 0.140, p = 0.096). Conclusions Prehabilitation, including nutrition and exercise, is effective in increasing skeletal muscle mass during neoadjuvant chemotherapy for older patients with esophageal cancer. Trial Registration Japan Registry of Clinical Trials: jRCT s051190016