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Randomized Controlled Trial
. 2013 Mar;34(2):282-95.
doi: 10.1016/j.cct.2012.12.003. Epub 2012 Dec 22.

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial

Collaborators, Affiliations
Randomized Controlled Trial

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial

Cheryl L Rock et al. Contemp Clin Trials. 2013 Mar.

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.

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Conflict of interest statement

Disclosure statement

All authors state that they have no actual or potential conflict of interest including any financial, personal or other relationship with other people or organizations within three years of beginning the work submitted that could have inappropriately influenced their work.

Figures

Fig. 1
Fig. 1
Potential effect of weight loss on hormonal and biological mediators linking obesity to breast cancer recurrence (IL-6, interleukin-6; CRP, C-reactive protein; TNF-α, tumor necrosis factor-α; SHBG, sex hormone binding globulin)
Fig. 2
Fig. 2
CONSORT diagram

References

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