A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer
The prevalence of obesity has increased rapidly in recent years. Epidemiological studies
since the 1970's have strongly suggested that excess body weight gain may be a major risk
factor for many cancers including breast cancer. In addition, once diagnosed with breast
cancer, women who are overweight or obese experience worse outcomes despite standard local
and adjuvant therapy. Furthermore, most women gain weight following a diagnosis of breast
cancer, and this weight gain may increase risk of recurrence by 40-50% and breast
cancer-related mortality by 53-60%.
A great deal of effort has been made for many years to explain the relationship between
obesity and breast cancer. Molecularly, the relationship involves dynamic and complex
interactions between a milieu of hormones, cytokines, adipokines, affecting cell signaling
and potentially epigenetic pathways. Recently, studies in postmenopausal women have shown
that weight loss modulates these cytokines and adipokines favorably. Inflammation associated
with obesity can also be characterized pathologically when macrophages surround necrotic
adipocytes in what are called crown-like structures (CLS). Furthermore, increased central
obesity as measured by waist-to-hip ratios, may be associated with hypermethylation of
certain breast cancer genes, and physical activity can reduce methylation of certain breast
cancer-associated genes.
The Women's Intervention Nutrition Study (WINS) demonstrated that women with early-stage
breast cancer receiving conventional cancer management randomized to a dietary intervention
group had lower risk of relapse compared to those in a control group in those who lost
weight. While women with a diagnosis of breast cancer are therefore recommended to maintain
ideal body weight, limited progress has been made in developing feasible weight loss
programs. However, collaborators from the Welch Center for Prevention, Epidemiology, and
Clinical Research at the Johns Hopkins University have recently reported impressive and
sustained weight loss in randomized controlled trials designated Practice-based
Opportunities for Weight Reduction (POWER) in obese women with at least one cardiovascular
risk factor using a remote-support weight loss intervention.
The overall goal of this study is to determine the effectiveness of the remote-support
weight loss intervention of the POWER study, designated POWER-remote, in women with early
breast cancer who are overweight or obese, and to assess the effects of weight loss of ≥5%
body weight at 6 months and on biomarkers associated with obesity, inflammation, and breast
cancer. The data will be used to implement a clinical intervention available to all
overweight and obese women with breast cancer, and to design definitive studies assessing
the impact of weight loss and biomarker modulation on risk of recurrent disease or
development of new primary breast cancers.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in body weight
To compare the proportion of women with early stage breast cancer, who have completed all local therapy and adjuvant chemotherapy, who lose ≥5% of their baseline body weight after 6 and 12 months between a control arm (self-directed weight loss) and an experimental arm (POWER-remote)
After 12 months
No
Vered Stearns, M.D.
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
J12128
NCT01871116
June 2013
June 2016
Name | Location |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |