A Study of Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women after Treatment for Early-Stage Breast Cancer

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Full Title

A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women with Early Stage Breast Cancer

Purpose

This study will compare the effects of different amounts of aerobic exercise on heart and lung (cardiorespiratory) fitness in post-menopausal women who completed treatment for early-stage breast cancer. Researchers will study the effects of different exercise programs on oxygen use, heart pumping ability, lung function, and blood vessel health. Participants will be randomly assigned to one of four groups:

  • Group A: 300 minutes of supervised walking each week for 16 weeks followed by “usual care,” which will not include exercise treatment. Participants will receive monthly check-in calls from the study team until week 32.
  • Group B: Supervised walking sessions for 150 minutes each week for 32 weeks.
  • Group C: Supervised walking sessions for 300 minutes each week for 32 weeks.
  • Group D: Supervised walking sessions for 150 minutes each week for 16 weeks followed by usual care and monthly check-in calls until week 32.

Who Can Join

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

  • Participants must be post-menopausal women who completed surgery plus chemotherapy, radiation therapy, or trastuzumab for stage I-III breast cancer at least one year but no more than five years before starting the study.
  • Participants must have a fitness level that is below that expected for their age.
  • This study is for women ages 21-80.

For more information about this study, please contact Jessica Scott at 646-888-8103.

Protocol

20-130

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT04458532