Abstract
Obesity is a poor prognostic factor and is negatively related to quality of life (QOL) in breast cancer survivors. Exercise and Nutrition to Enhance Recovery and Good Health for You is the largest weight loss trial completed among cancer survivors. Percent losses in body weight with an intensive group-based intervention versus an attention control were 6.0 versus 1.5 % (p < 0.0001) and 3.7 versus 1.3 % (p < 0.0001) at 12 and 24 months, respectively. ENERGY also was designed to answer the research question: Does weight loss significantly improve vitality and physical function (key components of QOL)? 692 breast cancer survivors (BMI: 25–45 kg/m2) at 4 US sites were randomized to a year-long intensive intervention of 52 group sessions and telephone counseling contacts versus a non-intensive (control) of two in-person counseling sessions. Weight, self-reported QOL, and symptoms were measured semi-annually for two years. Significant decreases in physical function and increases in symptoms were observed among controls from baseline to 6 months, but not in the intervention arm, −3.45 (95 % Confidence Interval [CI] −6.10, −0.79, p = 0.0109) and 0.10 (95 %CI 0.04, 0.16, p = 0.0021), respectively. Improvements in vitality were seen in both arms but trended toward greater improvement in the intervention arm −2.72 (95 % CI −5.45, 0.01, p = 0.0508). These differences diminished over time; however, depressive symptoms increased in the intervention versus control arms and became significant at 24 months, −1.64 (95 % CI −3.13, −0.15, p = 0.0308). Increased QOL has been reported in shorter term diet and exercise trials among cancer survivors. These longer term data suggest that diet and exercise interventions improve some aspects of QOL, but these benefits may diminish over time.
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Acknowledgments
This study was supported by NCI Grant CA148791. Management of stored biological samples at the UCSD Coordinating Center was facilitated by the Diet and Physical Activity Shared Resource of the Moores UCSD Cancer Center (NCI Cancer Center Support Grant CA23100). The Colorado Clinical Translational Sciences Institute Grant (NIH CTSI Grant TR001082) supported study activities at the University of Colorado. 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). The authors thank the data and safety monitoring committee: Bernard Rosner, Ph.D, Joanne Mortimer, MD, Ken Fujioka MD, Frank Greenway, MD, and Linda Litzau. The authors thank Catherine Alfano, Ph.D (Program Officer), and Julia Rowland, Ph.D, NIH Office of Cancer Survivorship, and also Robert Croyle, Ph.D, NIH Division of Cancer Control and Population Sciences, for their assistance, guidance, and support.
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The primary data were made available to the investigators for independent central review and analyses. JL performed the statistical analyses. WDW wrote the first draft of the manuscript, with review and revision by the other authors. All authors had full access to all the data in the study, made the decision to submit these data for publication, were involved in writing the manuscript and agreed on the final content of the manuscript.
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All authors declare no competing interests, with the only exception being Dr. Wolin who reports equity from Scale Down LLC and Coeus Health LLC, personal fees from Takeda, and a pending patent for weight management software.
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On behalf of ENERGY Trial Group. The members of ENERGY Trial Group are given in Appendix.
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Appendix: The ENERGY Trial Group
Appendix: The ENERGY Trial Group
University of California, San Diego: Cheryl Rock, Ph.D, RD, Bilge Pakiz, EdD, Barbara Parker, MD, Christine Zoumas, MS, RD, Shirley Flatt, MS, Hava Shoshana Barkai, MS, RD, Dennis Heath, MS, Lea Jacinto, Mila Pruitt.
University of California, Los Angeles: Patricia A. Ganz, MD.
University of Colorado Denver: Tim Byers, MD, MPH, Rebecca Sedjo, Ph.D, Holly Wyatt, MD, Anthony Elias, MD, James Hill, Ph.D, Jhenny Hernandez, MBA, Kim Gorman, MS, RD, Carmen Faust, MPH, Anna Van Pelt, MPH.
Washington University in St. Louis: Graham Colditz, MD, Kathleen Wolin, ScD, Jingxia Liu, Ph.D, Michael Naughton, MD, Casey Fagin, MA, Jennifer Tappenden, Sonya Izadi.
University of Alabama at Birmingham: Wendy Demark-Wahnefried, Ph.D, RD, Helen Krontiras, MD, Maria Azrad, Ph.D, RD, Cindy Blair, Ph.D, Lahnor Powell, DO, and Laura Lee Goree, MS, RD.
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Demark-Wahnefried, W., Colditz, G.A., Rock, C.L. et al. Quality of life outcomes from the Exercise and Nutrition Enhance Recovery and Good Health for You (ENERGY)-randomized weight loss trial among breast cancer survivors. Breast Cancer Res Treat 154, 329–337 (2015). https://doi.org/10.1007/s10549-015-3627-5
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DOI: https://doi.org/10.1007/s10549-015-3627-5