Cardiac Rehabilitation to Improve Breast Cancer Outcomes

Breast Cancer Clinical Trial

— CRIBCO  

Official title:

Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867667
• Other study ID #: UMCC 2023.010
• Secondary ID: HUM00230386
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: Anna Lamport
• Phone: 734-764-3832
• Email: alamport[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiovascular Diseases

Intervention

Other:
• Cardiac Rehab
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

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.	Change in muscular strength will be assessed using 5-RM tests. The tests will be performed for leg extension, leg flexion, chest press, lat pull down, and bicep curl.	up to 12 weeks after enrollment
Secondary	changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.	Change in muscular strength will be assessed using 5-RM tests. The tests will be performed for leg extension, leg flexion, chest press, lat pull down, and bicep curl.	up to 12 weeks after enrollment