Clinical trial NCT05763563: Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
Official title: Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphoma
Leukemia
Myeloma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Cancer and Aging Research Group
First posted: 2023-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants that Enroll and Consent - Enrollment Feasibility
timeFrame: Up to 12 Months
measure: Percentage of Participants that Complete Study Assessments - Retention Feasibility
timeFrame: Up to 3 Months
measure: Adherence - Feasibility
timeFrame: Up to 3 Months
measure: Participant Evaluation of Feasibility and Acceptability - Acceptability
timeFrame: Up to 3 Months
measure: Participant Self-Reported Musculoskeletal Injuries - Safety
timeFrame: Up to 3 Months
measure: Objective physical functioning and fitness - Baseline
timeFrame: At Baseline
measure: Objective physical functioning and fitness - Follow-up
timeFrame: Up to 3 Months
measure: Participant Skeletal Muscle Index (SMI) - Baseline
timeFrame: Baseline
measure: Participant Skeletal Muscle Index (SMI) - Follow-up
timeFrame: After CAR-T Therapy, Up to 6 Months
measure: Participants Health-Related Quality of Life - Baseline
timeFrame: Baseline
measure: Participants Health-Related Quality of Life - At 3 Months
timeFrame: Up to 3 Months
measure: Participants Health-Related Quality of Life - At 6 Months
timeFrame: Up to 6 Months
measure: Participant Self Reported Exercise - Baseline
timeFrame: Baseline
measure: Participant Self Reported Exercise - At 3 Months
timeFrame: Up to 3 Months
measure: Participant Self Reported Exercise - At 6 Months
timeFrame: Up to 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nathan Parker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Ciara Freeman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: