CLINICAL TRIAL article
Front. Oncol.
Sec. Cancer Epidemiology and Prevention
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1682244
This article is part of the Research TopicIntegrating Nutrition in Cancer Therapy: Approaches to Improve Patient Outcomes and SurvivalView all 8 articles
A Randomized Trial of a Multimodal Lifestyle Intervention in Cancer Survivors
Provisionally accepted
Justin Brown1*
Phillip Nauta2Darryl Whitehead2Benjamin R Dubin2Ryan Nash2Kate Blumberg2Tamara Green2John Brown2
Stephanie L. E. Compton1Gerald P Miletello3- 1AdventHealth, Orlando, United States
- 2Louisiana State University Pennington Biomedical Research Center, Baton Rouge, United States
- 3Franciscan Missionaries of Our Lady University, Baton Rouge, United States
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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 cm3 (95% CI: -380.4, -27.7); P=0.019], and improved self-reported vitality [12.2 points (95% CI: 1.6, 22.8); P=0.024] and social functioning [14.2 points (95% CI: 1.1, 27.4); P=0.034]. MLI did not reduce lean mass [-0.2 kg (95% CI: -0.8, 0.4); P=0.52] or bone mineral density [0.004 g/cm3 (95% CI: -0.012, 0.020); P=0.63]. There were no serious adverse events. 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 healthspan after cancer. Registration clinicaltrials.gov NCT04987359
Keywords: Obesity, Exercise, Cancer, lifestyle modification, Weight Loss, cardiovascular fitness
Received: 08 Aug 2025; Accepted: 22 Sep 2025.
Copyright: © 2025 Brown, Nauta, Whitehead, Dubin, Nash, Blumberg, Green, Brown, Compton and Miletello. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Justin Brown, justin.brown4@adventhealth.com
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