Cardiac Rehab for Breast Cancer Survivors

(CRIBCO Trial)

Overseen By Anna Lamport

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Planned surgery, High-risk cardiovascular, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop a new cardiac rehabilitation program specifically for breast cancer survivors at higher risk of heart disease. The program consists of 12 visits over eight weeks, fewer than the typical 32 visits for heart patients. It targets individuals who have had stage I-III breast cancer, completed most treatments in the last 18 months, and are at increased risk for heart disease, such as those with high blood pressure, diabetes, or a history of smoking. Participants must be able to exercise and should not have severe heart issues or planned surgeries during the study. As an unphased trial, this study offers a unique opportunity to contribute to a specialized program that could benefit future breast cancer survivors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants should have completed all oncologic treatments except for oral maintenance therapy. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this cardiac rehabilitation program is safe for breast cancer survivors?

Research has shown that cardiac rehabilitation, a specialized exercise program, is generally safe for breast cancer survivors. One study found that this exercise can improve heart health and increase survival rates. Another study found that these programs are safe and may help reduce heart issues in women who have undergone breast cancer treatment.

These findings suggest that cardiac rehab is well-tolerated, with no major safety concerns reported. It appears to be a promising option for improving heart health in breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cardiac rehabilitation is unique because it’s applying a heart health approach to help breast cancer survivors. Typically, breast cancer treatments focus on targeting the cancer itself, but cardiac rehab aims to improve overall well-being and heart function, which can be affected by cancer treatments. Researchers are excited because this method could enhance recovery and quality of life by addressing cardiovascular health, offering a holistic benefit that current cancer-focused treatments don’t directly provide.

What evidence suggests that this cardiac rehabilitation program is effective for breast cancer survivors?

Research shows that cardiac rehabilitation, which participants in this trial will receive, can greatly benefit cancer survivors, including those who have had breast cancer. Studies have found that exercise-based cardiac rehab improves fitness and survival rates for cancer survivors. It can also boost muscle strength and enhance quality of life. For breast cancer survivors, early findings suggest that cardiac rehab may help manage heart health after cancer treatment. Evidence indicates that exercise during rehab might reduce some negative effects of cancer treatment on the heart. ^{1 2 3 6 7}

Who Is on the Research Team?

David Lipps, PhD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors, aged 18 or older, who have completed their main treatments within the last 18 months and are at risk of developing cardiovascular disease. Participants must be able to exercise and give informed consent. Those with metastatic cancer, high-risk heart conditions under treatment, planned surgeries during the study period, or inability to consent are excluded.

Inclusion Criteria

I am at high risk for heart disease.

My breast cancer is at an early to mid-stage (I-III).

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

My cancer has spread to other parts of my body.

I am scheduled for surgery during the study.

You are not able to do physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week hybrid cardiac rehabilitation program designed for breast cancer survivors at enhanced risk of cardiovascular disease

12 weeks

12 visits (in-person) over the first 8 weeks

Follow-up

Participants are monitored for changes in cardiovascular fitness and muscular strength after the rehabilitation program

up to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Rehabilitation

Trial Overview The trial is testing a new cardiac rehabilitation program designed specifically for breast cancer survivors at risk of heart disease. It involves attending 12 rehab sessions over eight weeks and aims to improve heart health without overburdening the existing cardiac rehab services meant for patients with severe heart conditions.

How Is the Trial Designed?

Group I: Cardiac Rehabilitation to Improve Breast Cancer Outcomes Experimental Treatment 1 Intervention

12 weeks of Cardiac Rehab

Cardiac Rehabilitation is already approved in United States, European Union for the following indications:

Approved in United States as Cardiac Rehabilitation for:

• Cardiovascular disease prevention in cancer survivors
• Improvement of cardiorespiratory fitness in cancer patients

Approved in European Union as Cardio-Oncology Rehabilitation for:

• Reduction of cardiovascular risk in cancer survivors
• Management of cardiotoxicity related to cancer therapies

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

Cardiac rehabilitation programs are beneficial for cancer survivors, with over 60% completion rates and improvements in various health and psychosocial outcomes, based on a review of nine studies involving 662 participants.

Integrating cancer survivors into cardiac rehabilitation sessions, whether mixed with cardiac patients or in dedicated sessions, shows promise in enhancing quality of life and physical functioning post-cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Programs for Cancer Survivors: A Scoping Review. Cuthbertson, CC., Pearce, EE., Valle, CG., et al.[2022]

The rise in cancer survival rates has led to an increase in patients facing both cancer and cardiovascular diseases, highlighting the need for integrated care in cardio-oncology to manage shared risk factors and mitigate the cardiotoxic effects of cancer treatments.

The Cardio-Oncology REhabilitation (CORE) program is an exercise-based intervention designed to improve cardiovascular health in cancer patients, offering benefits such as enhanced cardiorespiratory fitness, better quality of life, and psychological support, while also addressing barriers to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The core components of cardio-oncology rehabilitation. Venturini, E., Gilchrist, S., Corsi, E., et al.[2022]

Cardiac rehabilitation (CR) for cancer survivors shows low-to-moderate quality in reporting and moderate-to-high risk of bias, which affects the reliability of the findings and their application in clinical practice.

Despite the quality concerns, survivors who completed CR demonstrated improved cardiorespiratory fitness and reduced fatigue compared to those who did not participate in CR, suggesting potential benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Quality and Impact of Cardiac Rehabilitation in Cancer Survivors: A Systematic Review and Meta-Analysis. Fakhraei, R., Peck BKin, SS., Abdel-Qadir, H., et al.[2022]

Cancer survivors often face impairments from their disease and treatment that can be improved through rehabilitation, highlighting the need for specialized programs.

Existing community-based cardiac rehabilitation (CR) programs can be adapted to create effective oncology rehabilitation services, requiring only minor adjustments, and preliminary evidence shows that these programs can enhance both psychological and physiological well-being in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based oncology rehabilitation: leveraging the cardiac rehabilitation model. Dittus, KL., Lakoski, SG., Savage, PD., et al.[2018]

As the number of cancer survivors increases, so does the risk of cardiovascular disease (CVD) among them, highlighting the need for integrated care in cancer treatment.

Cardio-oncology rehabilitation (CORE) is a new approach designed to reduce CVD risk and enhance fitness in cancer survivors through tailored exercise and cardiac rehabilitation, addressing the emerging issue of cancer treatment-related cardiovascular disease (CTRCD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology rehabilitation- challenges and opportunities to improve cardiovascular outcomes in cancer patients and survivors. Sase, K., Kida, K., Furukawa, Y.[2021]

A 4-week supervised multimodal rehabilitation program significantly improved quality of life and reduced fatigue in breast cancer patients who completed chemotherapy, as shown by assessments using the EORTC QLQ-C30 and QLQ-BR23 questionnaires.

Patients who started the rehabilitation program early (EEG) experienced greater improvements in physical and emotional functions, as well as reduced cancer-related symptoms, compared to those who started later (DEG).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 4-week multimodal rehabilitation program on quality of life, cardiopulmonary function, and fatigue in breast cancer patients. Do, J., Cho, Y., Jeon, J.[2020]

Women with breast cancer and treatment-related heart failure showed significant improvements in peak aerobic power (VO2peak) after cardiac rehabilitation, similar to age-matched women with coronary artery disease, indicating the efficacy of rehabilitation for both groups.

Completion rates for the cardiac rehabilitation program were comparable between women with breast cancer and those with coronary artery disease, suggesting that cardiac rehabilitation is equally accessible and beneficial for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for women with breast cancer and treatment-related heart failure compared with coronary artery disease: A retrospective study. Bonsignore, A., Marzolini, S., Oh, P.[2018]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

A 15-week multidimensional rehabilitation program for cancer survivors significantly improved health-related quality of life, exercise capacity, and muscle strength, with effect sizes ranging from 0.38 to 0.99, and these benefits were mostly maintained at a 3-month follow-up.

The majority of cancer survivors (80% before and 58% after the program) preferred the comprehensive multidimensional approach over single-component rehabilitation programs, indicating a strong patient preference for holistic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidimensional cancer rehabilitation program for cancer survivors: effectiveness on health-related quality of life. van Weert, E., Hoekstra-Weebers, J., Grol, B., et al.[2015]

The center-based cardiac rehabilitation (CBCR) program showed significantly higher adherence (90.3%) and satisfaction among cancer survivors at increased cardiovascular risk compared to community-based exercise training (CBET) (68.4%).

Both programs were safe, with no major cardiovascular events reported; however, CBCR had fewer exercise-related adverse events (7) compared to CBET (20), indicating a potentially safer environment for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, safety, and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial. Viamonte, SG., Joaquim, A., Alves, A., et al.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2810101

Cardio-Oncology Rehabilitation for Cancer Survivors With ... Recent data from a large noncontrolled study showed that exercise-based CR was associated with improve cardiorespiratory fitness and survival in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314747/

Cardio-oncology rehabilitation and exercise - PubMed Central The aim of this whitepaper is to review the current state of the literature on the effects of cardio-oncology rehabilitation and exercise (CORE) programmes ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000679

Cardio-Oncology Rehabilitation to Manage Cardiovascular ... In general, current evidence indicates that exercise may attenuate the cancer treatment–induced declines in CRF, although confirmation in larger ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388924002059

Effectiveness of cardiac rehabilitation in cancer survivors Our findings demonstrate that cardiac rehabilitation training significantly enhances muscle strength and quality of life in cancer patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8178006/

A Cardiac Rehabilitation Program for Breast Cancer Survivors The purpose of this study was to determine the feasibility and preliminary efficacy of a cardiac rehabilitation (CR) intervention in the breast cancer ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06251401

Cardiac Rehabilitation for Breast Cancer Survivors Data will be collected at baseline, following program completion, and 6-months after program completion. The primary outcomes are measures of study feasibility.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0033062024000239

Exercise-based cardio-oncology rehabilitation for ... This study suggests that CORe programs are safe and may help attenuate LVEF decline in BC women receiving cardiotoxic therapy and reduce BMI in obese patients.