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Alliance A011401

Breast Cancer Weight Loss Study (BWEL Study)

Status:

Recruiting | Phase III 

Official Title:

Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Study Purpose:

To determine if losing weight may help prevent breast cancer from coming back.

Interventions:

  • Health Education with or without a 2-Year weight loss program 
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: A Health Education Program that can include educational materials, newsletters, webinars, a cookbook, etc.
  • ARM II: The same Health Education Program described above, with the addition of a 2-year weight loss program that includes a health coach and is designed to help women lose about 10% of their starting weight

Patients will be followed every 6 months from start of study for the first 3 years, and then annually until 10 years from start of study.

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

Diagnosis:

Breast cancer patients who have had surgery and whose cancer also has additional higher risk features (i.e. – positive lymph nodes, large size, and/or triple negative marker status)

Marker Status:

Must be Her2 negative, all ER/PR statuses are accepted

Prior Therapy:

Patients must have had surgery and completed chemotherapy (before or after surgery). They may or may not have had radiation. If appropriate, patients are allowed to be on hormone therapy at the same time as the study medication.

Must be registered to the study within 12 months of diagnosis.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Alliance A011401

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!