Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Lymphoma; Myeloma; Leukemia

Treatments: Behavioral: Optional Aerobic Exercise Procedure; Behavioral: Aerobic Exercise; Radiation: Optional In-Person Exercise Sessions; Behavioral: Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05763563

MCC-22115

Details and patient eligibility

About

The purpose of the study is to evaluate an exercise program for individuals preparing for Chimeric Antigen Receptor (CAR) T-cell immunotherapy for hematological malignancies.

Enrollment: 20 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥65 years
• Lymphoma, leukemia, or myeloma with commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Able to read and speak English fluently
• Capable of providing informed consent
• For optional, tele-supervised aerobic training procedure involving stationary bicycle delivery, participants must live within a 2-hour drive of Moffitt Cancer Center as determined via Google Maps.

Exclusion criteria

• Regular engagement in Resistance training (2x/week targeting all major muscle groups)
• Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
• Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
• Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT using body weight
• Numeric pain rating scale of ≥ 7 out of 10
• Myopathic or rheumatologic disease that impacts physical function
• Cognitive, visual, or auditory limitations that preclude safe engagement in remotely-supervised resistance training sessions or independent aerobic exercise (as determined by patients' treating oncologists and specified in clinic notes outlining disease history).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Exercise prehabilitation

Experimental group

Description:

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:

Radiation: Optional In-Person Exercise Sessions

Behavioral: Resistance Training

Behavioral: Aerobic Exercise

Behavioral: Optional Aerobic Exercise Procedure