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Trial Title:
Cardiac Rehabilitation to Improve Breast Cancer Outcomes
NCT ID:
NCT05867667
Condition:
Breast Cancer
Cardiovascular Diseases
Conditions: Official terms:
Breast Neoplasms
Cardiovascular Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cardiac Rehab
Description:
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
Arm group label:
Cardiac Rehabilitation to Improve Breast Cancer Outcomes
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anna Lamport
Phone:
734-764-3832
Email:
alamport@umich.edu
Investigator:
Last name:
David Lipps, PhD
Email:
Principal Investigator
Start date:
March 19, 2024
Completion date:
August 2025
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05867667
