A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women with Breast Cancer

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Full Title

Pharmacodynamic Response to Exercise Treatment and Plant-Based Diet in Overweight/Obese Postmenopausal Women with Primary Hormone Receptor Positive Breast Cancer: A Phase 2 Randomized Control Trial

Purpose

Researchers are doing this study to see if exercise and a plant-based diet have an impact on aromatase levels in overweight women receiving aromatase inhibitors for breast cancer (such as letrozole, anastrozole, and exemestane). Aromatase is an enzyme that promotes the production of estrogen, which can fuel some breast cancers.

Studies have shown that women who are overweight tend to have higher aromatase levels in their breast tissue. Researchers think that exercise combined with a plant-based diet may help slow the growth of cancer by decreasing aromatase levels, promoting other positive changes in the body, and causing weight loss.

Participants in this study will be assigned to either the counseling group or the intervention group. Those in the counseling group will receive a home-based general physical activity program and nutrition counseling for 6 months (24 weeks). Those in the intervention group will participate in walking sessions up to 7 times a week and follow a plant-based diet for 6 months. Participants in both groups will receive a treadmill for home use and have two breast tissue biopsies as part of this study.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I-III hormone receptor-positive, HER2-negative breast cancer and be postmenopausal.
  • At least 3 months must pass between the completion of any prior chemotherapy or radiation therapy and entry into the study.
  • Patients must be receiving an aromatase inhibitor.
  • Patients must be overweight (BMI 27 or more) and sedentary (less than 150 minutes of exercise weekly).
  • This study is for women age 18 and older.

For more information about this study, please contact Dr. Neil Iyengar at 646-888-8103.

Protocol

19-486

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Jones, Lee, PhD