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A Randomized Study Evaluating the Effect of a Remote-Based Weight Loss Program (POWER-remote) on Biomarkers in Women With Early Stage Breast Cancer

Phase 2
18 Years
Not Enrolling
Early Stage Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- Women

- 18 years or older

- Ductal carcinoma in situ (DCIS) or stage I-III invasive breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs, and willing to lose >5% of their body
weight. NOTE: Participants may not have documented weight loss greater than 5% of
body weight from time of diagnosis. Exceptions that are felt to be due to surgical or
other procedures (e.g., mastectomies or reconstruction) may be allowed with prior
approval of the Protocol Chair/designee.

- Patients must have completed local therapy (i.e. surgery and radiation therapy), and
any preoperative or adjuvant chemotherapy within >3 and <36 months of registration.
NOTE: Concurrent anti-HER2 therapy is permitted. Concurrent endocrine breast cancer
therapy is permitted; patients may enroll >3 months after initiation of hormone
therapy if expected to continue the same hormone agent for at least the first 6
months of the study. Concurrent enrollment in other interventional or drug clinical
trials is at the discretion of the Protocol Chair.

- Willingness to change diet, physical activity and weight.

- To ensure compliance with the POWER-remote and PatientViewpoint programs, patients
must meet the following: prior experience with web forms and feels able to use the
POWER-remote web program and PatientViewpoint; has or is able to download Internet
Explorer 8+, Firefox 3.0+, Safari 4.0+, Chrome 4.0+, and Adobe Flash Player 10;
familiarity with and access to internet at least 4 days per week; use of an email
program or willing and able to establish one for this study; and, able to read and
write the English language without assistance.

- Patient is aware of her diagnosis, understands the study regimen, its requirements,
risks, and discomforts, and is able and willing to sign an informed consent form.

Exclusion Criteria:

- History of another prior cancer within the last 5 years, with the exception of
another breast cancer, adequately treated cone-biopsied in situ carcinoma of the
cervix uteri, and basal or squamous cell carcinoma of the skin

- Medical condition likely to hinder accurate measurement of weight, including any
condition: for which weight loss is contraindicated, which would likely cause weight
loss, or which would affect adipokine and inflammatory markers (e.g., end stage renal
disease (ESRD) on dialysis, cirrhosis, autoimmune disease, adrenal disease, and
history of bariatric surgery).

- The use of the following medications are excluded: insulin or sulfonlyureas; patients
with thyroid disease who are not on stable doses of thyroid medication for at least
the past 6 months; medications that cause weight loss (e.g., topiramate, bupropion,
exenatide, lorcaserin, phentermine or orlistat) within the past 3 months; medications
that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids,
lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone
replacement therapy) within the past 3 months; medications that may affect adipokine
or inflammatory markers (e.g., sulfonylureas, glitazones, insulin, steroids, ACE
inhibitors, beta blockers and statins) unless started ≥3 months prior to enrollment,
or chronic NSAIDS (defined as use of ≥3 times a week) for ≥1 month.

- Pregnant or nursing within past 6 months, or plans to become pregnant in the next

- Currently enrolled or planning to enroll in a weight loss program (e.g., Innergy,
Weight Watchers, Jenny Craig, Nutrisystem, and Medifast).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in body weight

Outcome Description:

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)

Outcome Time Frame:

After 12 months

Safety Issue:


Principal Investigator

Vered Stearns, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

June 2016

Related Keywords:

  • Early Stage Breast Cancer
  • breast cancer
  • early stage
  • weight loss
  • Breast Neoplasms
  • Weight Loss



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410