Clinical trial NCT05867667: Cardiac Rehabilitation to Improve Breast Cancer Outcomes
Official title: Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Cardiovascular Diseases
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.
timeFrame: up to 12 weeks after enrollment
Secondary outcomes:
measure: changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
timeFrame: up to 12 weeks after enrollment
measure: changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
timeFrame: up to 12 weeks after enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: David Lipps, PhD
role: PRINCIPAL_INVESTIGATOR
References: