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Breast Cancer WEight Loss Study (BWEL Study)

NCT02750826 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3177

Last updated 2025-01-13

No results posted yet for this study

Summary

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Conditions

  • Breast Carcinoma

Interventions

OTHER

Health Education Program

OTHER

Weight Loss Intervention

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Division of Cancer Control

    collaborator UNKNOWN

  • NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)

    collaborator UNKNOWN

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Jennifer Ligibel, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-16
Primary Completion
2030-05-30
Completion
2030-05-30

Countries

  • United States
  • Canada
  • Guam
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02750826 on ClinicalTrials.gov