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

Lymphoma Clinical Trial

Official title:

Feasibility Of Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For Chimeric Antigen Receptor (CAR) T-Cell Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763563
• Other study ID #: MCC-22115
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Nathan Parker, PhD, MPH
• Phone: 813-745-4673
• Email: Nathan.Parker[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

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).

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myeloma

Intervention

Behavioral:
• Resistance Training
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo CART-T therapy. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously.
• Aerobic Exercise
Participants will be encouraged to perform =30 minutes of moderate-intensity aerobic exercise on =3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Cancer and Aging Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants that Enroll and Consent - Enrollment Feasibility	Enrollment will be considered feasible if =60% of eligible and approached patients actually consent and enroll	Up to 12 Months
Primary	Percentage of Participants that Complete Study Assessments - Retention Feasibility	Retention will be considered feasible if =70% of participants complete study measures	Up to 3 Months
Primary	Adherence - Feasibility	Adherence will be based on participants attending = 70% of tele-RT sessions on average and performing = 70% of prescribed moderate-intensity aerobic exercise per week	Up to 3 Months
Primary	Participant Evaluation of Feasibility and Acceptability - Acceptability	Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores =4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.	Up to 3 Months
Primary	Participant Self-Reported Musculoskeletal Injuries - Safety	The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator of the safety variable will be the number of exercise sessions performed by the participant (tele-resistance training plus aerobic exercise sessions lasting =10 minutes). The intervention will be considered safe if the rate of musculoskeletal injuries (i.e., muscle strains or pulls, sprains, exacerbated bone pain, fractures or breaks, or other adverse health events incurred during exercise sessions) is lower than the published metric of 11.9 injuries per 1000 sessions, as used as a benchmark in previous exercise oncology research	Up to 3 Months
Primary	Objective physical functioning and fitness - Baseline	Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.	At Baseline
Primary	Objective physical functioning and fitness - Follow-up	Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.	Up to 3 Months
Primary	Participant Skeletal Muscle Index (SMI) - Baseline	Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans	Baseline
Primary	Participant Skeletal Muscle Index (SMI) - Follow-up	Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans	After CAR-T Therapy, Up to 6 Months
Primary	Participants Health-Related Quality of Life - Baseline	Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey	Baseline
Primary	Participants Health-Related Quality of Life - At 3 Months	Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey	Up to 3 Months
Primary	Participants Health-Related Quality of Life - At 6 Months	Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey	Up to 6 Months
Primary	Participant Self Reported Exercise - Baseline	Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise	Baseline
Primary	Participant Self Reported Exercise - At 3 Months	Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise	Up to 3 Months
Primary	Participant Self Reported Exercise - At 6 Months	Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise	Up to 6 Months

External Links

•   Moffitt Cancer Center Clinical Trial Search