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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence - Feasibility

Objective physical functioning and fitness - Baseline

Objective physical functioning and fitness - Follow-up

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exercise prehabilitationExperimental Treatment4 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

Resistance Training

2019

Completed Phase 2

~1230

Aerobic Exercise

2013

Completed Early Phase 1

~1350