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CAR T-cell Therapy
Exercise Prehabilitation for Blood Cancers
N/A
Recruiting
Led By Nathan Parker, PhD, MPH
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial looks at how exercise can help people prepare for cancer therapy with CAR T-cells.
Who is the study for?
This trial is for people aged 65 or older with leukemia, lymphoma, or myeloma who are set to receive CAR-T cell therapy in at least 4 weeks. They should be relatively active (able to perform daily activities), speak English fluently, and can consent. It's not for those already doing regular resistance training, have exercise safety concerns, severe heart/lung disease, recent serious injuries that affect exercise ability, intense pain, muscle/rheumatic diseases affecting function or major cognitive/sensory issues.Check my eligibility
What is being tested?
The study tests an exercise program consisting of resistance and aerobic exercises for older adults preparing for CAR-T cell therapy. The goal is to see if exercising before treatment can help improve outcomes and recovery from the immunotherapy used to treat blood cancers.See study design
What are the potential side effects?
Since this trial involves physical exercise programs rather than medication, side effects may include typical risks associated with starting a new workout routine such as muscle soreness or strain. However specific side effects will depend on individual health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence - Feasibility
Objective physical functioning and fitness - Baseline
Objective physical functioning and fitness - Follow-up
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Exercise prehabilitationExperimental Treatment2 Interventions
Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo CAR-T therapy (Approximately 4-6 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic Exercise
2013
Completed Early Phase 1
~1310
Resistance Training
2019
Completed Phase 2
~1190
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,462 Total Patients Enrolled
41 Trials studying Leukemia
2,003 Patients Enrolled for Leukemia
Cancer and Aging Research GroupUNKNOWN
Nathan Parker, PhD, MPHPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a recent injury that stops me from doing exercises using my body weight.My pain level is 7 or higher on a scale of 0 to 10.I do not have severe heart or lung problems.I am 65 years old or older.I can take care of myself and am up and about more than half of my waking hours.I am scheduled for FDA-approved CAR-T therapy in 4 weeks or more.I can understand and agree to the study's details.I have a muscle or joint disease that affects my ability to move.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise prehabilitation
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 uppermost limit for participants in this investigation?
"Affirmative. The clinicaltrial.gov website displays details that confirm this medical trial is presently enrolling participants; it was first published on February 23rd 2023 and was last updated on February 28th 2023. Twenty patients need to be recruited across one centre."
Answered by AI
Is this study open to recruitment at the moment?
"Affirmative. Clinicaltrials.gov data indicates that this medical trial is currently accepting patients, with the initial posting on February 23rd of 2023 and a recent update from just five days ago. The study requires an enrollment of 20 individuals at one site."
Answered by AI
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