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NCT05867667 | Recruiting | Breast Cancer

Cardiac Rehabilitation to Improve Breast Cancer Outcomes
Sponsor:

University of Michigan Rogel Cancer Center

Brief Summary:

To develop a novel, proactive cardiac rehabilitation program for breast cancer survivors at enhanced risk of cardiovascular disease. Considering this program is secondary to the Michigan Medicine Cardiac Rehabilitation program's goal to manage cardiac patients, the hybrid program has been designed that limits utilization of cardiac rehabilitation to 12 visits over the first eight weeks of the intervention compared to 32 visits for cardiovascular patients.

Condition or disease

Breast Cancer

Cardiovascular Diseases

Intervention/treatment

Cardiac Rehab

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : None (Open Label)
Primary Purpose : Supportive Care
Official Title : Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)
Actual Study Start Date : March 19, 2024
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025
Arm Intervention/treatment

Experimental: Cardiac Rehabilitation to Improve Breast Cancer Outcomes

12 weeks of Cardiac Rehab

Other: Cardiac Rehab
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Breast cancer diagnosis stage I-III
  • Within 18-months of treatment completion (defined as completion of all oncologic treatments expect oral maintenance therapy)
  • Age 18 years or older
  • At increased risk for cardiovascular disease based on one of the following; a.Treatment with either anthracycline-based or anti-HER2 therapy-based treatment regimen plus the presence of: >2 cardiovascular heart disease risk factors (smoking, hypertension, diabetes mellitus, obesity, dyslipidemia), OR Age (>60 years) at cancer treatment, OR Left ventricular ejection fraction <50%as determined with a clinically ordered echo scan within 6 months of enrollment, b.Treatment with anthracycline followed by trastuzumab
  • Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
  • Planned surgery during the study period.
  • Under cardiology care for known high-risk cardiovascular disease defined as the presence of any of the following: severe, unrevascularized coronary artery disease, severe valvular heart disease, advanced heart failure with a left ventricular ejection fraction <35%)
  • Metastatic cancer
  • Unable to exercise (e.g., inability to complete a modified stress test or musculoskeletal condition that prevents adequate participation in exercise)
  • Adults unable to give consent, pregnant or lactating women, and prisoners are excluded from this study.
Cardiac Rehabilitation to Improve Breast Cancer Outcomes

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Cardiac Rehabilitation to Improve Breast Cancer Outcomes

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Locations

Recruiting

United States, road cancer

University of Michigan Rogel Cancer Center

Ann Arbor, road cancer, United States, 48109