Trial Title:
Exercise Prehabilitation Among Older Patients With Hematological Malignancies Preparing For CAR-T Cell Immunotherapy
NCT ID:
NCT05763563
Condition:
Lymphoma
Leukemia
Myeloma
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Resistance Training
Description:
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.
Arm group label:
Exercise prehabilitation
Intervention type:
Behavioral
Intervention name:
Aerobic Exercise
Description:
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
Arm group label:
Exercise prehabilitation
Intervention type:
Behavioral
Intervention name:
Optional Aerobic Exercise Procedure
Description:
Participants will be encouraged to complete 3 tele-supervised aerobic training sessions
per week, each lasting 30 minutes. Participants will be encouraged to achieve moderate
exercise intensity based on heart rate visualized on PM5 monitors. Participants will
report their heart rates every 3-5 minutes during an exercise session and be encouraged
to adjust pedaling cadence or flywheel resistance accordingly to achieve moderate
intensity.
Exercise trainers will access logged heart rate ranges (64-76% of age-predicted maximum
heart rate) to provide individualized and appropriate guidance during sessions.
Participants who are untrained or otherwise uncomfortable maintaining moderate aerobic
intensity for 30 minutes will be encouraged to gradually increase the duration and
intensity of their sessions until they are meeting these guidelines.
Arm group label:
Exercise prehabilitation
Intervention type:
Radiation
Intervention name:
Optional In-Person Exercise Sessions
Description:
Participants who prefer to complete RT and/or aerobic exercise sessions in-person will be
allowed to do so. These sessions will be conducted in the Moffitt Promotes Resilience in
Oncology Via Exercise (MPROVE) Laboratory using the same equipment participants would use
for Zoom sessions, with guidance and supervision from certified exercise trainers.
Arm group label:
Exercise prehabilitation
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.
Criteria for 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).
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Carmella
Phone:
813-745-0956
Email:
rachel.carmella@moffitt.org
Investigator:
Last name:
Nathan Parker, PhD, MPH
Email:
Principal Investigator
Investigator:
Last name:
Ciara Freeman, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Frederick Locke, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Jain, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Julio Chavez, MD, MS
Email:
Sub-Investigator
Investigator:
Last name:
Bijal Shah, MD, MS
Email:
Sub-Investigator
Investigator:
Last name:
Omar Casteneda Pugliani, MD
Email:
Sub-Investigator
Investigator:
Last name:
Doris Hansen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Taiga Nishihori, MD
Email:
Sub-Investigator
Investigator:
Last name:
Melissa Alsina, MD
Email:
Sub-Investigator
Investigator:
Last name:
Brandon Blue, MD
Email:
Sub-Investigator
Investigator:
Last name:
Rachid Baz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Rawan Faramand, MD
Email:
Sub-Investigator
Investigator:
Last name:
Heather Jim, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Laura Oswald, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jongphil Kim, PhD
Email:
Sub-Investigator
Start date:
February 21, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Cancer and Aging Research Group
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763563
https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=22115
