Breast cancer is the most common invasive cancer among women in developed countries. Obesity is a major risk factor for breast cancer recurrence and mortality in both pre- and postmenopausal women. Co-morbid medical conditions are common among breast cancer survivors. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is a 4-year randomized clinical trial of 693 overweight/obese women aged ≥21years diagnosed with any early stage breast cancer (stages I[≥1cm]-III) within the previous five years, designed to demonstrate the feasibility of achieving sustained weight loss and to examine the impact of weight loss on quality of life and co-morbidities, and to enable future exploration of biochemical mechanisms linking obesity to lower likelihood of disease-free survival. This trial is strategically designed as a vanguard for a fully-powered trial of women who will be evaluated for breast cancer recurrence and disease-free survival. Participants were recruited between 2010 and 2012 at four sites, had completed initial therapies, and had a body mass index between 25 and 45kg/m2. The intervention featured a group-based cognitive-behavioral weight loss program with telephone counseling and tailored newsletters to support initial weight loss and subsequent maintenance, with the goal of 7% weight loss at two years. This study has high potential to have a major impact on clinical management and outcomes after a breast cancer diagnosis. This trial initiates the effort to establish weight loss support for overweight or obese breast cancer survivors as a new standard of clinical care.
Bibliographical noteFunding Information:
This publication also was made possible by grant number UL1 RR024992 from the National Center for Research Resources (NCRR) , a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research . Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the National Center for Research Resources or NIH. We thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, for the use of the Tissue Procurement Core, which provided sample storage and processing (supported in part by an NCI Cancer Center Support Grant CA91842).
This study was supported by NCI grant CA148791 . Preliminary studies to develop the intervention components were supported by NCI grants CA90413 , CA101489 , CA81191 , and CA106919 . Management of stored biological samples at the UCSD Coordinating Center was facilitated by the Nutrition Shared Resource of the Moores UCSD Cancer Center (NCI Cancer Center Support Grant CA23100).
- Breast cancer
- Quality of life
- Weight reduction