Cardiac Rehabilitation to Improve Breast Cancer Outcomes

NCT05867667 | Terminated

• 2 other identifiers: UMCC 2023.010HUM00230386
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.

  Change in cardiovascular fitness will be based on endpoints related to aerobic and anaerobic thresholds, including an increase in post maximal oxygen consumption (VO2max). VO2max will be assessed by indirect calorimetry (COSMED) during a graded exercise stress test using the Bruce protocol.

  up to 12 weeks after enrollment

Secondary Outcomes (2)

• changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.

  up to 12 weeks after enrollment

• changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.

  up to 12 weeks after enrollment

Study Arms (1)

Cardiac Rehabilitation to Improve Breast Cancer Outcomes

EXPERIMENTAL

12 weeks of Cardiac Rehab

Other: Cardiac Rehab

Interventions

Cardiac Rehab OTHER

Cardiac Rehab 2x per week and home exercise 1x per week: weeks 1-4 Cardiac Rehab 1x per week and home exercise 2x per week: weeks 5-8, Home exercise 3x per week: weeks 9-12

Cardiac Rehabilitation to Improve Breast Cancer Outcomes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Lipps, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: March 19, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)