Grant Number:	1R01CA148791-01 Interpret this number
Primary Investigator:	Rock, Cheryl
Organization:	University Of California, San Diego
Project Title:	Reducing Breast Cancer Recurrence with Weight Loss: a Vanguard Trial
Fiscal Year:	2010

DESCRIPTION (provided by applicant): The high incidence of breast cancer coupled with earlier diagnosis and more effective therapies has resulted in over 2.5 million American women who are now breast cancer survivors. Excess adiposity is a major adverse prognostic factor post-diagnosis for women with both pre- and postmenopausal breast cancer and may be particularly relevant among women of various minority groups. Despite potential importance, there has never been a clinical trial to determine whether weight loss and maintenance of that loss reduces recurrence risk. Mechanisms that tie adiposity and physical inactivity to increased risk of breast cancer recurrence are not fully understood but include higher endogenous estrogens and insulin, and alterations in cytokines and other factors. Up to 30% of breast cancer survivors experience dysphoria that endures beyond completion of treatment and may be of clinical significance. Psychosocial problems and comorbid medical conditions are likely to be favorably affected by weight loss and increased physical activity in obese breast cancer survivors. We propose a 4-year trial of 800 overweight or obese (BMI >27 and <40 kg/m2) women aged 21 and older who have been diagnosed with stage IC, II, or IIIA breast cancer. The primary specific aim of the project is: (1) To conduct a 4-year vanguard randomized controlled trial with the primary endpoint of weight loss among 800 breast cancer survivors, following all subjects for 2 years after randomization. Our primary hypothesis is that weight loss of at least 7% can be achieved and maintained in this target population. Secondary aims are: (2) To use the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to conduct a cost-effectiveness analysis that includes an assessment of the impact of the intervention on medical comorbid conditions; (3) To assess the impact of the intervention on quality of life (QOL), particularly physical functioning and fatigue; and (4) To prospectively collect blood and DNA samples to enable analysis of potential mechanisms and differential response across subgroups. Our research strategy joins experienced investigators from five of the leading cancer centers, a multi-disciplinary team with outstanding experience in diet and exercise interventions, cancer survivorship, nutritional epidemiology, breast oncology trials, and breast cancer outcomes research. The weight loss intervention utilizes a cognitive-behavioral group-based program, telephone counseling and home-based support, developed and tested in previous successful studies conducted by the project investigators. As a vanguard trial, this project will test an intervention using accessible strategies that can be adopted widely in clinical practice and community-based programs and is strategically designed to lead to a fully-powered trial of 2500 subjects for cancer outcomes. If the improvements in QOL that we expect to find can be demonstrated in this trial of 800 survivors, this finding could itself change the norms of clinical practice. If the eventual full trial can document lower recurrence risk with this same intervention, this trial initiates the effort to establish weight control support for breast cancer survivors as a new standard of care.




Adult weight gain accelerates the onset of breast cancer.
Authors: Azrad M. , Blair C.K. , Rock C.L. , Sedjo R.L. , Wolin K.Y. , Demark-Wahnefried W. .
Source: Breast Cancer Research And Treatment, 2019-05-09 00:00:00.0; , .
EPub date: 2019-05-09 00:00:00.0.
PMID: 31073792
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Changes in Body Mass Index and Physical Activity Predict Changes in Vitality During a Weight Loss Trial in Breast Cancer Survivors.
Authors: Kenzik K.M. , Demark-Wahnefried W. , Ganz P.A. , Colditz G. , Rock C.L. , Rogers L.Q. .
Source: Annals Of Behavioral Medicine : A Publication Of The Society Of Behavioral Medicine, 2018-11-12 00:00:00.0; 52(12), p. 999-1009.
PMID: 29617707
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Impact Of A Behavioral Weight Loss Intervention On Comorbidities In Overweight And Obese Breast Cancer Survivors
Authors: Sedjo R.L. , Flatt S.W. , Byers T. , Colditz G.A. , Demark-Wahnefried W. , Ganz P.A. , Wolin K.Y. , Elias A. , Krontiras H. , Liu J. , et al. .
Source: Supportive Care In Cancer : Official Journal Of The Multinational Association Of Supportive Care In Cancer, 2016 Aug; 24(8), p. 3285-93.
PMID: 26945570
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Correlates of quality of life in overweight or obese breast cancer survivors at enrollment into a weight loss trial.
Authors: Pakiz B. , Ganz P.A. , Sedjo R.L. , Flatt S.W. , Demark-Wahnefried W. , Liu J. , Wolin K.Y. , Rock C.L. .
Source: Psycho-oncology, 2016 Feb; 25(2), p. 142-9.
PMID: 25920528
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Cancer Prevention: Obstacles, Challenges and the Road Ahead.
Authors: Meyskens F.L. , Mukhtar H. , Rock C.L. , Cuzick J. , Kensler T.W. , Yang C.S. , Ramsey S.D. , Lippman S.M. , Alberts D.S. .
Source: Journal Of The National Cancer Institute, 2016 Feb; 108(2), .
PMID: 26547931
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Physical activity levels of overweight or obese breast cancer survivors: correlates at entry into a weight loss intervention study.
Authors: Liu F.X. , Flatt S.W. , Pakiz B. , Sedjo R.L. , Wolin K.Y. , Blair C.K. , Demark-Wahnefried W. , Rock C.L. .
Source: Supportive Care In Cancer : Official Journal Of The Multinational Association Of Supportive Care In Cancer, 2016 Jan; 24(1), p. 173-80.
PMID: 25975675
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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.
Authors: Demark-Wahnefried W. , Colditz G.A. , Rock C.L. , Sedjo R.L. , Liu J. , Wolin K.Y. , Krontiras H. , Byers T. , Pakiz B. , Parker B.A. , et al. .
Source: Breast Cancer Research And Treatment, 2015 Nov; 154(2), p. 329-37.
PMID: 26518022
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Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors.
Authors: Rock C.L. , Flatt S.W. , Byers T.E. , Colditz G.A. , Demark-Wahnefried W. , Ganz P.A. , Wolin K.Y. , Elias A. , Krontiras H. , Liu J. , et al. .
Source: Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology, 2015-10-01 00:00:00.0; 33(28), p. 3169-76.
EPub date: 2015-10-01 00:00:00.0.
PMID: 26282657
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Effect of weight loss on bone health in overweight/obese postmenopausal breast cancer survivors.
Authors: Toriola A.T. , Liu J. , Ganz P.A. , Colditz G.A. , Yang L. , Izadi S. , Naughton M.J. , Schwartz A.L. , Wolin K.Y. .
Source: Breast Cancer Research And Treatment, 2015 Aug; 152(3), p. 637-43.
PMID: 26175059
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Weight gain prior to entry into a weight-loss intervention study among overweight and obese breast cancer survivors.
Authors: Sedjo R.L. , Byers T. , Ganz P.A. , Colditz G.A. , Demark-Wahnefried W. , Wolin K.Y. , Azrad M. , Rock C.L. .
Source: Journal Of Cancer Survivorship : Research And Practice, 2014 Sep; 8(3), p. 410-8.
PMID: 24599421
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The association between adiposity and breast cancer recurrence and survival: A review of the recent literature.
Authors: Azrad M. , Demark-Wahnefried W. .
Source: Current Nutrition Reports, 2014 Mar; 3(1), p. 9-15.
PMID: 24533234
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To your health: how does the latest research on alcohol and breast cancer inform clinical practice?
Authors: Demark-Wahnefried W. , Goodwin P.J. .
Source: Journal Of Clinical Oncology : Official Journal Of The American Society Of Clinical Oncology, 2013-06-01 00:00:00.0; 31(16), p. 1917-9.
EPub date: 2013-06-01 00:00:00.0.
PMID: 23569302
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Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial.
Authors: Rock C.L. , Byers T.E. , Colditz G.A. , Demark-Wahnefried W. , Ganz P.A. , Wolin K.Y. , Elias A. , Krontiras H. , Liu J. , Naughton M. , et al. .
Source: Contemporary Clinical Trials, 2013 Mar; 34(2), p. 282-95.
PMID: 23266440
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Physical activity and mammographic breast density: a systematic review.
Authors: Yaghjyan L. , Colditz G.A. , Wolin K. .
Source: Breast Cancer Research And Treatment, 2012 Sep; 135(2), p. 367-80.
PMID: 22814722
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The role of obesity in cancer survival and recurrence.
Authors: Demark-Wahnefried W. , Platz E.A. , Ligibel J.A. , Blair C.K. , Courneya K.S. , Meyerhardt J.A. , Ganz P.A. , Rock C.L. , Schmitz K.H. , Wadden T. , et al. .
Source: Cancer Epidemiology, Biomarkers & Prevention : A Publication Of The American Association For Cancer Research, Cosponsored By The American Society Of Preventive Oncology, 2012 Aug; 21(8), p. 1244-59.
PMID: 22695735
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Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial.
Authors: Rock C.L. , Flatt S.W. , Sherwood N.E. , Karanja N. , Pakiz B. , Thomson C.A. .
Source: Jama : The Journal Of The American Medical Association, 2010-10-27 00:00:00.0; 304(16), p. 1803-10.
EPub date: 2010-10-27 00:00:00.0.
PMID: 20935338
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