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, Tim E Byers, Graham A Colditz, Wendy Demark-Wahnefried, Patricia A Ganz, Kathleen Y Wolin, Anthony Elias, Helen Krontiras, Jingxia Liu, Michael Naughton, Bilgé Pakiz, Barbara A Parker, Rebecca L Sedjo, Holly Wyatt, Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial Group, Cheryl Rock, Bilge Pakiz, Barbara Parker, Chis Zoumas, Shirley Flatt, Hava Shoshana Barkai, Dennis Heath, Lea Jacinto, Mila Pruitt, Patricia Ganz, Tim Byers, Rebecca Sedjo, Holly Wyatt, Anthony Elias, James Hill, Jhenny Hernandez, Kim Gorman, Carmen Faust, Anna Van Pelt, Graham Colditz, Kathleen Wolin, Jingxia Liu, Michael Naughton, Casey Fagin, Jennifer Tappenden, Sonya Izadi, Wendy Demark- Wahnefried, Helen Krontiras, Maria Azrad, Cindy Blair, Lahnor Powell, Laura Lee Goree, Karen Kubas, Cheryl L Rock, Tim E Byers, Graham A Colditz, Wendy Demark-Wahnefried, Patricia A Ganz, Kathleen Y Wolin, Anthony Elias, Helen Krontiras, Jingxia Liu, Michael Naughton, Bilgé Pakiz, Barbara A Parker, Rebecca L Sedjo, Holly Wyatt, Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial Group, Cheryl Rock, Bilge Pakiz, Barbara Parker, Chis Zoumas, Shirley Flatt, Hava Shoshana Barkai, Dennis Heath, Lea Jacinto, Mila Pruitt, Patricia Ganz, Tim Byers, Rebecca Sedjo, Holly Wyatt, Anthony Elias, James Hill, Jhenny Hernandez, Kim Gorman, Carmen Faust, Anna Van Pelt, Graham Colditz, Kathleen Wolin, Jingxia Liu, Michael Naughton, Casey Fagin, Jennifer Tappenden, Sonya Izadi, Wendy Demark- Wahnefried, Helen Krontiras, Maria Azrad, Cindy Blair, Lahnor Powell, Laura Lee Goree, Karen Kubas

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.

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.

Copyright © 2012 Elsevier Inc. All rights reserved.

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

    1. AICR/WCRF. Food, Nutrition, Physical Activity, and the Prevention of Cancer: a Global Perspective. London: World Cancer Research Fund; 2007.
    1. American Cancer Society. Cancer Facts & Figures 2012. Atlanta: American Cancer Society;
    1. Ries L, Melbert D, Krapcho M, Stinchcomb D, et al. SEER Cancer Statistics Review 1975–2005. Bethesda, MD: National Cancer Institute; 2008.
    1. Demark-Wahnefried W, Campbell KL, Hayes SC. Weight management and its role in breast cancer rehabilitation. Cancer. 2012;1188(Suppl):2277–2287.
    1. Chlebowski RT, Aiello E, McTiernan A. Weight loss in breast cancer patient management. J Clin Oncol. 2002;204:1128–1143.
    1. Majed B, Moreau T, Senouci K, Salmon RJ, et al. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008;1112:329–342.
    1. Patterson RE, Cadmus LA, Emond JA, Pierce JP. Physical activity, diet, adiposity and female breast cancer prognosis: a review of the epidemiologic literature. Maturitas. 2010;661:5–15.
    1. Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010;1233:627–635.
    1. Daling JR, Malone KE, Doody DR, Johnson LG, et al. Relation of body mass index to tumor markers and survival among young women with invasive ductal breast carcinoma. Cancer. 2001;924:720–729.
    1. Khaodhiar L, McCowen KC, Blackburn GL. Obesity and its comorbid conditions. Clin Cornerstone. 1999;23:17–31.
    1. CDC. Center for Disease Control and Prevention. Overweight and Obesity. 2009 Available from: .
    1. Bines J, Gradishar WJ. Primary care issues for the breast cancer survivor. Compr Ther. 1997;239:605–611.
    1. Brown BW, Brauner C, Minnotte MC. Noncancer deaths in white adult cancer patients. J Natl Cancer Inst. 1993;8512:979–987.
    1. Ahern TP, Lash TL, Thwin SS, Silliman RA. Impact of acquired comorbidities on all-cause mortality rates among older breast cancer survivors. Med Care. 2009;471:73–79.
    1. Kaaks R, Rinaldi S, Key TJ, Berrino F, et al. Postmenopausal serum androgens, oestrogens and breast cancer risk: the European prospective investigation into cancer and nutrition. Endocr Relat Cancer. 2005;124:1071–1082.
    1. Lann D, LeRoith D. The role of endocrine insulin-like growth factor-I and insulin in breast cancer. J Mammary Gland Biol Neoplasia. 2008;134:371–379.
    1. Ray A. Adipokine leptin in obesity-related pathology of breast cancer. J Biosci. 2012;372:289–294.
    1. Key TJ, Appleby PN, Reeves GK, Roddam A, et al. Body mass index, serum sex hormones, and breast cancer risk in postmenopausal women. J Natl Cancer Inst. 2003;9516:1218–1226.
    1. Morisset AS, Blouin K, Tchernof A. Impact of diet and adiposity on circulating levels of sex hormone-binding globulin and androgens. Nutr Rev. 2008;669:506–516.
    1. Sinicrope FA, Dannenberg AJ. Obesity and breast cancer prognosis: weight of the evidence. J Clin Oncol. 2011;291:4–7.
    1. Rock CL, Flatt SW, Laughlin GA, Gold EB, et al. Reproductive steroid hormones and recurrence-free survival in women with a history of breast cancer. Cancer Epidemiol Biomarkers Prev. 2008;173:614–620.
    1. Bastard JP, Maachi M, Lagathu C, Kim MJ, et al. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006;171:4–12.
    1. Festa A, D'Agostino R, Jr, Williams K, Karter AJ, et al. The relation of body fat mass and distribution to markers of chronic inflammation. Int J Obes Relat Metab Disord. 2001;2510:1407–1415.
    1. Lithgow D, Covington C. Chronic inflammation and breast pathology: a theoretical model. Biol Res Nurs. 2005;72:118–129.
    1. Mefferd K, Nichols JF, Pakiz B, Rock CL. A cognitive behavioral therapy intervention to promote weight loss improves body composition and blood lipid profiles among overweight breast cancer survivors. Breast Cancer Res Treat. 2007;1042:145–152.
    1. Yeter K, Rock CL, Pakiz B, Bardwell WA, et al. Depressive symptoms, eating psychopathology, and physical activity in obese breast cancer survivors. Psychooncology. 2006;156:453–462.
    1. Pakiz B, Flatt S, Zoumas-Morse C, Rock C. AICR Research Conference on Food, Nutrition, Physical Activity and Cancer. Washington, D.C.: 2008. Risk factors after participating in a one-year cognitive-behavioral therapy weight management program for obese breast cancer survivors.
    1. Taylor DL, Nichols JF, Pakiz B, Bardwell WA, et al. Relationships between cardiorespiratory fitness, physical activity, and psychosocial variables in overweight and obese breast cancer survivors. Int J Behav Med. 2010;174:264–270.
    1. Rock CL, Pande C, Flatt SW, Ying C, et al. Favorable changes in serum estrogens and other biological factors after weight loss in overweight or obese breast cancer survivors. Clinical Breast Cancer. In press.
    1. Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, et al. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007;2519:2709–2718.
    1. Demark-Wahnefried W, Clipp EC, McBride C, Lobach DF, et al. Design of FRESH START: a randomized trial of exercise and diet among cancer survivors. Med Sci Sports Exerc. 2003;353:415–424.
    1. Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, et al. Promoting Healthy Lifestyles Among Older Cancer Survivors to Improve Health and Preserve Function. Journal of American Gerontological Association. 2009
    1. Snyder DC, Morey MC, Sloane R, Stull V, et al. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009;184:429–439.
    1. Morey MC, Snyder DC, Sloane R, Cohen HJ, et al. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009;30118:1883–1891.
    1. Sallis JF, Calfas KJ, Alcaraz JE, Gehrman C, et al. Potential mediators of change in a physical activity promotion course for university students: Project GRAD. Ann Behav Med. 1999;212:149–158.
    1. Bandura A. Social Learning Theory. Englewood Cliffs: Prentice-Hall; 1977.
    1. Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice-Hall; 1986.
    1. Bandura A. Self-Efficacy: The Exercise of Self-Control. New York: W.H. Freeman; 1997.
    1. Miller WR, Rollnick S. Motivational Interviewing: preparing People to Change Addictive Behavior. New York: Guilford Press; 1991.
    1. DiLillo V, Siegfried NJ, West DS. Incorporating motivational interviewing into behavioral obesity treatment. Cognitive and Behavioral Practice. 2003;10:120–130.
    1. Beck AT. Cognitive therapy and the emotional disorders. New York: International Universities Press; 1976.
    1. Beck JS. Cognitive therapy: Basics and beyond. New York: Guildford; 1995.
    1. Cooper Z, Fairburn CG. A new cognitive behavioural approach to the treatment of obesity. Behav Res Ther. 2001;395:499–511.
    1. Fairburn CG, Cooper Z. New perspectives on dietary and behavioural treatments for obesity. Int J Obes Relat Metab Disord. 1996;20(Suppl 1):S9–S13.
    1. Cooper A, Fairburn CG, Hawker DM. Cognitive-Behavioral Treatment of Obesity. New York: Guilford Press; 2003.
    1. Wilson Acceptance and change in the treatment of eating disorders and obesity. Behavior Therapy. 1996;273:417–439.
    1. IOM. Crossing the quality chasm: A new health system for the 21st Century. Washington, DC: Committee on Quality of Health Care in America. Institute of Medicine; 2001.
    1. Jakicic JM, Marcus BH, Gallagher KI, Napolitano M, et al. Effect of exercise duration and intensity on weight loss in overweight, sedentary women: a randomized trial. JAMA. 2003;29010:1323–1330.
    1. Jeffery RW, Wing RR, Sherwood NE, Tate DF. Physical activity and weight loss: does prescribing higher physical activity goals improve outcome? Am J Clin Nutr. 2003;784:684–689.
    1. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 427:1409–1426.
    1. NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY III. Available from: .
    1. NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY III CYCLE 2. Revised July 1993; Available from: .
    1. McArdle WD, Katch FI, Pechar GS, Jacobson L, et al. Reliability and interrelationships between maximal oxygen intake, physical work capacity and step-test scores in college women. Med Sci Sports. 1972;44:182–186.
    1. Milne HM, Wallman KE, Gordon S, Courneya KS. Effects of a combined aerobic and resistance exercise program in breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat. 2008;1082:279–288.
    1. Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, et al. The Automated Self-Administered 24-Hour Dietary Recall (ASA24): A Resource for Researchers, Clinicians, and Educators from the National Cancer Institute. J Acad Nutr Diet. 2012;1128:1134–1137.
    1. Brazier J, Usherwood T, Harper R, Thomas K. Deriving a Single Index Value for Health From the UK SF-36® Health Survey. J Clin Epidemiol. 1998;5111:1115–1128.
    1. Brazier J, Roberts J, Deverill M. The Evaluation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21:271–292.
    1. Ware J. SF-36 Health Survey update. In: Maruish ME, editor. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah (NJ): Lawrence Erlbaum Associates; 2004.
    1. Ware J, Jr, Sherbourne C. The MOS 36-item short-form health survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructions. Med Care. 1992;31:247–263.
    1. Brazier JE, Harper R, Jones NM, O'Cathain A, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;3056846:160–164.
    1. Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009;338:a3006.
    1. Burnam MA, Wells KB, Leake B, Landsverk J. Development of a brief screening instrument for detecting depressive disorders. Med Care. 1988;268:775–789.
    1. Murphy J. Psychiatric instrument development for primary care research: patient self-report questionnaire, report on contract 80M01428101D. Bethesda, Md.: National Institute of Mental Health; 1982.
    1. Bardwell WA, Ancoli-Israel S, Dimsdale JE. Comparison of the effects of depressive symptoms and apnea severity on fatigue in patients with obstructive sleep apnea: a replication study. J Affect Disord. 2007;971-3:181–186.
    1. Stanton AL, Bernaards CA, Ganz PA. The BCPT symptom scales: a measure of physical symptoms for women diagnosed with or at risk for breast cancer. J Natl Cancer Inst. 2005;976:448–456.
    1. Crespi CM, Ganz PA, Petersen L, Castillo A, et al. Refinement and psychometric evaluation of the impact of cancer scale. J Natl Cancer Inst. 2008;10021:1530–1541.
    1. Sangha O, Stucki G, Liang MH, Fossel AH, et al. The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003;492:156–163.
    1. Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;3466:393–403.
    1. Elmer PJ, Obarzanek E, Vollmer WM, Simons-Morton D, et al. Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. Ann Intern Med. 2006;1447:485–495.
    1. Harrell F. Regression modeling strategies: with applications to linear models, logistic regression and survival analysis. Springer; 2001.
    1. Gadbury GL, Coffey CS, Allison DB. Modern statistical methods for handling missing repeated measurements in obesity trial data: beyond LOCF. Obes Rev. 2003;43:175–184.
    1. Daniels MJ, Hogan JW. Missing Data in Longitudinal Studies, Strategies for Bayesian Modeling and Sensitivity Analysis. Boca Raton, FL: Chapman & Hall/CRC; 2008.
    1. Rosner B. Percentage Points for a Generalized ESD Many-Outlier Procedure. Technometrics. 1983;252:165–172.
    1. Fine JT, Colditz GA, Coakley EH, Moseley G, et al. A prospective study of weight change and health-related quality of life in women. JAMA. 1999;28222:2136–2142.
    1. Byers T, Sedjo RL. Does intentional weight loss reduce cancer risk? Diabetes Obes Metab. 2011;1312:1063–1072.
    1. Chlebowski RT, Blackburn GL, Thomson CA, Nixon DW, et al. Dietary fat reduction and breast cancer outcome: interim efficacy results from the Women's Intervention Nutrition Study. J Natl Cancer Inst. 2006;9824:1767–1776.
    1. Loprinzi CL, Athmann LM, Kardinal CG, O'Fallon JR, et al. Randomized trial of dietician counseling to try to prevent weight gain associated with breast cancer adjuvant chemotherapy. Oncology. 1996;533:228–332.
    1. Winningham ML, MacVicar MG, Bondoc M, Anderson JI, et al. Effect of aerobic exercise on body weight and composition in patients with breast cancer on adjuvant chemotherapy. Oncol Nurs Forum. 1989;165:683–689.
    1. Goodwin P, Esplen MJ, Butler K, Winocur J, et al. Multidisciplinary weight management in locoregional breast cancer: results of a phase II study. Breast Cancer Res Treat. 1998;481:53–64.
    1. McTiernan A, Ulrich C, Kumai C, Bean D, et al. Anthropometric and hormone effects of an eight-week exercise-diet intervention in breast cancer patients: results of a pilot study. Cancer Epidemiol Biomarkers Prev. 1998;76:477–481.
    1. Demark-Wahnefried W, Kenyon AJ, Eberle P, Skye A, et al. Preventing sarcopenic obesity among breast cancer patients who receive adjuvant chemotherapy: results of a feasibility study. Clin Exerc Physiol. 2002;41:44–49.
    1. Djuric Z, DiLaura NM, Jenkins I, Darga L, et al. Combining weight-loss counseling with the weight watchers plan for obese breast cancer survivors. Obes Res. 2002;107:657–665.
    1. Thomson CA, Stopeck AT, Bea JW, Cussler E, et al. Changes in body weight and metabolic indexes in overweight breast cancer survivors enrolled in a randomized trial of low-fat vs. reduced carbohydrate diets. Nutr Cancer. 2010;628:1142–1152.
    1. Befort CA, Klemp JR, Austin HL, Perri MG, et al. Outcomes of a weight loss intervention among rural breast cancer survivors. Breast Cancer Res Treat. 2012;1322:631–639.
    1. Pierce JP, Natarajan L, Caan BJ, Parker BA, et al. Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women's Healthy Eating and Living (WHEL) randomized trial. JAMA. 2007;2983:289–298.
    1. Cheng L, Swartz MD, Zhao H, Kapadia AS, et al. Hazard of recurrence among women after primary breast cancer treatment--a 10-year follow-up using data from SEER-Medicare. Cancer Epidemiol Biomarkers Prev. 2012;215:800–809.

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