POWER-remote Weight Loss Program in Early Stage Breast Cancer
This research is being done to assess the effectiveness of a weight loss program in women with early stage breast cancer whose body mass index (BMI) is in the overweight or obese range (>25). Weight loss is beneficial in improving cardiovascular risk factors and overall health, but may also decrease the chance of breast cancer coming back. A weight loss counseling program was studied in a general population and was found to be effective to help reduce weight over a 2 year period.
The main goal of this study is to determine if women with a recent diagnosis of early breast cancer will also lose weight with this program. To better understand the effect that weight loss has on women with breast cancer, we will compare the patterns in blood and breast tissue samples (tissue biopsies will be optional), and questionnaires evaluating different aspects of one's well-being, before and after a dietary intervention or no intervention.
Early Stage Breast Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer|
- Change in body weight [ Time Frame: After 12 months ] [ Designated as safety issue: No ]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)
- Change in biomarkers [ Time Frame: After 12 months ] [ Designated as safety issue: No ]To evaluate the effects of weight loss and POWER-remote on serum biomarkers (including fasting glucose, fasting lipids, fasting insulin, insulin like growth factor (IGF), high-sensitivity C-reactive protein (hsCRP), interleukin 1 and 6 (IL-1 and IL-6), tumor necrosis factor- alpha (TNF-α), leptin, adiponectin, and estradiol) at baseline and 6 months
- Change in PROs (Patient Reported Outcomes) [ Time Frame: After 12 months ] [ Designated as safety issue: No ]To evaluate the effects of weight loss and POWER-remote on PROs, with a specific interest in comparing the change in Physical Function at 6 months from baseline as a function of weight los
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Participants will start a weight loss program called POWER-remote for Breast Cancer Survivors. This program involves two main components: an online portion accessed on a computer through the internet and a telephone portion to help monitor progress.
Web-based weight loss program.
Active Comparator: Self-directed
Participants will receive a pamphlet entitled "Aim for a Healthy Weight", to help guide weight loss goals without access to the web-based POWER-remote system and coach support.
Pamphlet entitled "Aim for a Healthy Weight" will be given.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01871116
|Contact: Hopkins Breast Trials||HopkinsBreastTrials@jhmi.edu|
|Contact: Johns Hopkins Cancer Center Clinical Research Officefirstname.lastname@example.org|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287-0013|
|Contact: Hopkins Breast Trials HopkinsBreastTrials@jhmi.edu|
|Contact: Kimmel Cancer Center Clinical Research Office 410-955-8866 email@example.com|
|Principal Investigator: Vered Stearns, M.D.|
|Study Chair:||Vered Stearns, M.D.||Sidney Kimmel Comprehensive Cancer Center|