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.