Cardio-oncology Program for Bone Marrow Transplant Patients

Overseen By Cancer AnswerLine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Severe anemia, Untreated coronary disease, others

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

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special program designed for individuals preparing for a bone marrow transplant, a treatment for certain blood-related conditions. The program aims to improve heart health and fitness to reduce heart complications during the transplant process. Known as the Cardio-Oncology Prehabilitation program, it includes a personalized exercise plan and management of heart health risks over an eight-week period. This trial suits those scheduled for a bone marrow transplant evaluation who have a heart-related risk factor, such as high blood pressure or diabetes, and can walk unassisted. As an unphased trial, it offers a unique opportunity to enhance heart health before a transplant.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cardio-Oncology Prehabilitation program is safe for bone marrow transplant patients?

Research shows that exercise programs can be safe and beneficial for patients undergoing bone marrow transplants. Studies have found that these programs can enhance fitness and reduce heart-related issues. One study discovered that exercise is not only safe but also manageable for transplant patients, leading to improved health outcomes.

The Cardio-Oncology Prehabilitation program provides personalized exercise plans tailored to each patient's heart health. Early results suggest that this program is well-received and can help manage heart risks. While sources do not mention specific negative effects, exercise in similar situations has demonstrated positive safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cardio-Oncology Prehabilitation program is unique because it combines a personalized exercise regimen with the management of cardiovascular risk factors, all tailored specifically for bone marrow transplant patients. Unlike traditional treatments that may primarily focus on managing cardiovascular issues after they arise, this program proactively addresses these risks through a detailed cardiovascular assessment and an individualized approach. Researchers are excited about this trial because it could improve heart health in patients undergoing intensive treatments like bone marrow transplants, potentially enhancing overall treatment outcomes and quality of life.

What evidence suggests that the Cardio-Oncology Prehabilitation program is effective for improving cardiorespiratory fitness in bone marrow transplant patients?

Research shows that programs like prehabilitation, which include exercise, can help cancer patients improve their physical abilities and overall health. In this trial, participants will engage in a cardio-oncology program with individualized exercise prescriptions. Studies indicate that exercise benefits patients undergoing hematopoietic stem cell transplant (HSCT), both during and after treatment. These programs can lower the risk of heart-related problems. The cardio-oncology rehabilitation program in this trial focuses on maintaining heart health in cancer patients and identifying those at high risk for heart issues. Overall, adding exercise to cancer care has been shown to help manage heart problems related to treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Salim Hayek, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are about to receive a bone marrow transplant and need a heart check-up. They must be able to walk on their own and understand/sign consent forms. It's not for those with severe heart valve issues, recent fractures, extreme pain during movement, severe anemia, untreated major heart artery disease, balance problems or the most serious class of heart failure.

Inclusion Criteria

I can walk by myself without help.

I am referred for a heart check before a stem cell transplant.

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

Exclusion Criteria

I have severe heart failure.

Severe anemia (hemoglobin <7 gm/dl)

I have significant issues with my balance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Program

Participants undergo an 8-week cardio-oncology prehabilitation program to improve cardiorespiratory fitness and reduce cardiovascular complications

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after the prehabilitation program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardio-Oncology Prehabilitation program

Trial Overview The study tests if a special 'prehab' program focusing on the heart can improve fitness and reduce heart-related complications in patients at high risk before they undergo bone marrow transplantation.

How Is the Trial Designed?

Group I: Cardio-oncology program Experimental Treatment 1 Intervention

The cardio-oncology program consists of a multimodal approach, which includes individualized exercise prescription following a detailed CV assessment and medical management of CV risk factors occurring over 8 weeks.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

This pilot randomized controlled trial aims to assess the feasibility, acceptability, and safety of a home-based resistance training program for patients with hematological malignancies prior to undergoing hematopoietic stem cell transplant (HSCT).

The study will evaluate the impact of this prehabilitation exercise on physical function, body composition, bone mineral density, and patient-reported outcomes, with assessments occurring before HSCT and at 30 and 100 days post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMPROVE-BMT: a protocol for a pilot randomised controlled trial of prehabilitation exercise for adult haematopoietic stem cell transplant recipients. Potiaumpai, M., Schmitz, KH., Mineishi, S., et al.[2023]

Cancer treatments can lead to heart problems, which are a significant concern for patients from the start of treatment through survivorship.

Exercise has proven benefits for heart health but is not commonly used as a protective strategy in cancer care; this review highlights the need for integrating exercise into cardio-oncology practices to help prevent and manage heart issues related to cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Exercise Training into&#160;Cardio-Oncology Care: Current Evidence and Opportunities: JACC: CardioOncology State-of-the-Art Review. Wilson, RL., Christopher, CN., Yang, EH., et al.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A supervised exercise training program (SETP) was safe for women undergoing anthracycline chemotherapy for breast cancer and significantly improved their cardiorespiratory fitness, as indicated by increased estimated peak VO2.

However, the exercise program did not show significant effects on cardiac toxicity markers, such as left ventricular ejection fraction (LVEF), compared to usual care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial. Antunes, P., Joaquim, A., Sampaio, F., et al.[2023]

Cardiotoxicity from anti-cancer drugs is a significant concern, contributing to over 40% of cancer deaths, and is linked to mechanisms like DNA damage and oxidative stress.

Exercise training is safe and well-tolerated in cancer patients, leading to a 10-15% improvement in cardiorespiratory fitness, and may help counteract the adverse cardiovascular effects of cancer therapies, making tailored cardiac rehabilitation programs a promising option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation-Present and Future Perspectives. Elad, B., Habib, M., Caspi, O.[2022]

Cancer survivors are increasingly at risk of cardiovascular disease, which can be more deadly than recurrent cancer itself, highlighting the need for cardiovascular risk reduction strategies during and after cancer treatment.

Oncology nurses play a crucial role in identifying cardiovascular risks in cancer patients and implementing timely interventions to reduce morbidity and mortality associated with cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Needs in Cancer Treatment-Related Cardiotoxicity. Pituskin, E., Kirkham, AA., Cox-Kennett, N., et al.[2021]

A pilot study involving 30 hematopoietic stem cell transplant (HSCT) patients demonstrated that an 8-week cardiac rehabilitation (CR) program is safe and feasible, with no adverse events reported during the intervention.

Participants showed significant improvements in physical functioning, including grip strength, gait speed, and 6-minute walk test results, indicating that guided exercise can help HSCT survivors recover and even exceed their baseline activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation in Patients With Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Cardio-oncology Pilot Project. Rothe, D., Cox-Kennett, N., Buijs, DM., et al.[2019]

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]

Prehabilitation, which involves rehabilitation strategies before intensive cancer treatments, has been shown to improve functional outcomes and tolerability for patients undergoing surgery and other anti-cancer therapies.

Current evidence supports the integration of prehabilitation as a standard practice in oncology care, with future research needed to explore its effects on treatment responses and disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation is the Gateway to Better Functional Outcomes for Individuals with Cancer. Stout, NL., Fu, JB., Silver, JK.[2022]

A pilot study involving 34 patients undergoing haematopoietic stem cell transplantation (HSCT) demonstrated that a combined exercise and nutritional support program is feasible and safe, with high acceptability (82.4%) and low attrition (17.8%).

Participants showed significant improvements in fat-free mass (1.1 kg increase), physical performance (50 m increase in walking distance), and health-related quality of life, indicating that prehabilitation can enhance recovery outcomes for patients with haematologic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of exercise training and nutritional support prior to haematopoietic stem cell transplantation in patients with haematologic malignancies. Rupnik, E., Skerget, M., Sever, M., et al.[2021]

Patient-centric prehabilitation in oncology is essential for enhancing patient experiences and improving overall health outcomes while also reducing healthcare costs.

Nurses play a crucial role in the prehabilitation process, from patient assessment to intervention implementation, highlighting the need for more research and education to support interdisciplinary prehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation. An Interdisciplinary Patient-Centric Conceptual Framework. Renouf, T., Bates, A., Davis, JF., et al.[2022]

A 12-week home-based cardio-oncology rehabilitation (CORE) program using telerehabilitation was found to be safe and feasible for 11 hematological cancer survivors, with 80% adherence to the exercise sessions.

Participants showed a significant improvement in cardiorespiratory fitness, with an increase of 2.6 ml/kg/min and peak workload, indicating that this intervention can effectively enhance fitness levels in cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. Filakova, K., Janikova, A., Felsoci, M., et al.[2023]

Prehabilitative exercise significantly improves physical fitness in cancer patients, as evidenced by increases in maximal oxygen consumption and 6-minute walk distance, helping to counteract the negative effects of cancer surgery.

While the physical benefits of prehabilitative exercise are clear, its impact on psychosocial and biological outcomes is still uncertain, indicating a need for further research to establish comprehensive exercise guidelines for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitative Exercise for the Enhancement of Physical, Psychosocial, and Biological Outcomes Among Patients Diagnosed with Cancer. Lee, K., Zhou, J., Norris, MK., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-hematopoietic-stem-cell-transplantation-sct-6-2023-0b18a

Cardio-oncology Program for Bone Marrow Transplant ... Research shows that prehabilitation programs, which include exercise, can improve physical and functional outcomes for cancer patients before surgery. These ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03886909

Impact of Prehabilitation in Oncology Via Exercise- Bone ... Evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with ...

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

Cardio-Oncology Rehabilitation to Manage Cardiovascular ... This document introduces the concept of cardio-oncology rehabilitation, which includes identification of patients with cancer at high risk for cardiac ...

5. jacc.org jacc.org/doi/10.1016/j.jaccao.2023.08.008

Incorporating Exercise Training into Cardio-Oncology Care ... In this state-of-the-art review, the authors discuss cancer treatment–induced cardiotoxicities, review the existing evidence supporting the role of exercise.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11012812/

IMPROVE-BMT: A Pilot Randomized Controlled Trial of ... Conclusions: IMPROVE-BMT demonstrates that pragmatic exercise is highly feasible for HSCT recipients and can potentially lead to enhanced ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05945121

Study Details | NCT05945121 | Prehabilitation Program to ... To assess the feasibility and preliminary effectiveness of a Cardio-Oncology Prehabilitation program in patients at high-risk of developing Cardiovascular ...