Breast CancerCRIBCONCT05867667
Cardiac Rehabilitation to Improve Breast Cancer Outcomes
A study testing Cardiac Rehab in people with Breast Cancer and Cardiovascular Diseases, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cardiovascular Diseases
- What is being tested?
- Cardiac Rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 13 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)
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
- Being tested
- Cardiac Rehab
- Medical subject headings
- Breast Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation to Improve Breast Cancer Outcomes | Experimental | 12 weeks of Cardiac Rehab Receives: Other: Cardiac Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: up to 12 weeks after enrollment
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.
Measured: up to 12 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start19 Mar 2024
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Why it stopped: Insufficient Budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lipps, PhD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867667
- Sponsor's protocol ID
- UMCC 2023.010
- Other IDs
- HUM00230386
- Acronym
- CRIBCO
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation to Improve Breast Cancer Outcomes (CRIBCO)
- ClinicalTrials.gov ID
- NCT05867667
- Acronym / sponsor ID
- CRIBCO / UMCC 2023.010
- Conditions
- Breast Cancer, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Budget
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation to Improve Breast Cancer Outcomes | Experimental | Other: Cardiac Rehab12 weeks of Cardiac Rehab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac RehabCardiac 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 | Other | Cardiac Rehabilitation to Improve Breast Cancer Outcomes |
Primary outcome
Change in cardiovascular fitness (as assessed using VO2max) between baseline and after 12 weeks of participation in a tapered 12-week cardiac rehabilitation program.
Time frame: up to 12 weeks after enrollment
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.
2 secondary outcomes
changes in upper body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
Time frame: up to 12 weeks after enrollment
changes in lower body strength between baseline and after a 12-week hybrid cardiac rehabilitation program.
Time frame: up to 12 weeks after enrollment
Results and safety
The study was stopped early (reason given: Insufficient Budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lipps, PhD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehab in people with Breast Cancer and Cardiovascular Diseases, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 12 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.