A randomized trial of a multimodal lifestyle intervention in cancer survivors.

Introduction: Cancer survivors are often insufficiently physically active, have overweight or obesity, and suboptimal cardiorespiratory fitness. The Small Steps study evaluated a multimodal intervention to address these modifiable risk factors. Methods: The study randomized 33 cancer survivors to a 10-week multimodal lifestyle intervention (MLI) of exercise training and nutritional counseling or waitlist control (WLC). The co-primary endpoints included body weight and cardiorespiratory fitness capacity; secondary and exploratory endpoints included cardiometabolic and patient-reported measures. Endpoints were analyzed using analysis of covariance. Results: Participants had a mean (SD) age of 60.3 (14.0) years, 26 (79%) were White, and 18 (55%) were survivors of breast cancer. At baseline, the mean body weight was 94.9 (18.3) kg, and the submaximal cardiopulmonary fitness was 16.4 (5.0) mL/kg/min. As compared with WLC, MLI reduced body weight [-2.3 kg (95% CI: -3.6, -0.9); P = 0.0013; -2.8% (95% CI: -4.3, -1.3)] and increased cardiopulmonary fitness [2.0 mL/kg/min (95% CI: 0.3, 3.8); P = 0.022]. MLI reduced waist circumference [-2.9 cm (95% CI: -5.5, -0.3); P = 0.029], fat mass [-1.7 kg (95% CI: -2.9, -0.5); P = 0.005], visceral adipose tissue [-168.0 cm Discussion: The Small Steps program reduced body weight and improved cardiopulmonary fitness in survivors of various types of cancer. This program may contribute to improved health span after cancer. Clinical trial registration: clinicaltrials.gov, identifier NCT04987359.