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Cardio-oncology Program for Bone Marrow Transplant Patients
N/A
Recruiting
Led By Salim Hayek
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks post enrollment
Awards & highlights
Study Summary
This trial will test if a program can help cancer patients reduce the risk of cardiovascular events and improve their cardio-respiratory fitness.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves exercise as part of the prehabilitation program rather than medication, side effects may include typical exercise-related risks such as muscle soreness or strain but will depend on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks post enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks post enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Duration of Recruitment).
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (Recruitment Rate).
Feasibility of a cardio-oncology prehabilitation program in high-risk HSCT candidates (adherence to program- Days).
+10 moreSecondary outcome measures
Change in patient HSCT eligibility after an 8-week cardio-oncology prehabilitation program
Changes in patient reported quality of life after an 8-week cardio-oncology prehabilitation program
Difference in biomarkers after an 8-week cardio-oncology prehabilitation program
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cardio-oncology programExperimental Treatment1 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.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,114 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,251 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,840 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart failure.I have significant issues with my balance.I can walk by myself without help.I experience severe pain with basic movements.I am 18 years old or older.I am referred for a heart check before a stem cell transplant.I have been diagnosed with severe narrowing of my heart's aortic valve.I cannot walk or exercise without help.I have severe untreated heart artery disease.
Research Study Groups:
This trial has the following groups:- Group 1: Cardio-oncology program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary aim of this trial?
"The primary purpose of this medical trial, to be evaluated over an 8-week period post enrollment, is the determinaion of the feasibility of a cardio-oncology prehabilitation program in high risk HSCT candidates (retention Rates). Secondary objectives include assessing changes in patient-reported quality of life after an 8 week cardio-oncology prehabilitation program via EORTC QLQ-C30 responses on a 0 to 100 scale with higher scores representing better health outcomes. Additionally, biomarkers such as High Sensitivity Troponin I and BNP will also be measured along with suPAR levels from residual serum"
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Are there still opportunities for patients to participate in this research?
"As per clinicaltrials.gov, this medical investigation is currently inactive and no longer recruiting study participants. The trial was posted on July 1st 2023 but has since been edited on the 6th of that month. However, there are 38 alternative trials which presently open to recruitment."
Answered by AI
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