title: Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.
abstract: 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/m(2). 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.
authors.affiliation: University of California, La Jolla, CA 92093, USA. clrock@ucsd.edu
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Rock
authors.forename: Tim E
authors.initials: TE
authors.lastname: Byers
authors.forename: Graham A
authors.initials: GA
authors.lastname: Colditz
authors.forename: Wendy
authors.initials: W
authors.lastname: Demark-Wahnefried
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Ganz
authors.forename: Kathleen Y
authors.initials: KY
authors.lastname: Wolin
authors.forename: Anthony
authors.initials: A
authors.lastname: Elias
authors.forename: Helen
authors.initials: H
authors.lastname: Krontiras
authors.forename: Jingxia
authors.initials: J
authors.lastname: Liu
authors.forename: Michael
authors.initials: M
authors.lastname: Naughton
authors.forename: Bilgé
authors.initials: B
authors.lastname: Pakiz
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Parker
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Sedjo
authors.forename: Holly
authors.initials: H
authors.lastname: Wyatt
mesh_terms: D000368:Aged; D015992:Body Mass Index; D001943:Breast Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D015928:Cognitive Behavioral Therapy / Q000379:methods; D015897:Comorbidity; D004038:Diet, Reducing; D018572:Disease-Free Survival; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009765:Obesity / Q000453:epidemiology / Q000628:therapy*; D050177:Overweight / Q000453:epidemiology / Q000628:therapy; D011615:Psychotherapy, Group / Q000379:methods; D011788:Quality of Life; D016896:Treatment Outcome; D015431:Weight Loss; D061217:Weight Reduction Programs / Q000379:methods*