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Trial Title:
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
NCT ID:
NCT05706766
Condition:
Multiple Myeloma
Stem Cell Transplant Complications
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Autologous Stem Cell Transplant
Aerobic Exercise Program
Resistance Exercise Program
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PARE
Description:
Aerobic and resistance exercise program via Zoom platform.
Arm group label:
Exercise Group (PARE)
Other name:
Prehabilitation Aerobic and Resistance Exercise training program
Intervention type:
Behavioral
Intervention name:
Waitlist Control Group
Description:
Normal Activities.
Arm group label:
Waitlist Control Group
Summary:
The goal of this research study is to investigate whether a virtual, home-based,
prehabilitation aerobic and resistance exercise (PARE) training program implemented 8
weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma
participants will improve muscular strength, physical capacity, patient reported
outcomes, and cardiometabolic health outcomes.
The names of the study interventions involved in this study are:
- Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week
aerobic and resistance exercise program)
- Waitlist control (8-week normal activity behavior)
Detailed description:
This is a single-center, prospective, parallel-group, randomized controlled study that
will enroll patients diagnosed with multiple myeloma planning to receive autologous stem
cell transplant (ASCT).
Participants will be randomized into one of the intervention groups: Exercise Group
(PARE) versus Waitlist Control Group. Randomization means that participants are placed
into one of the treatment groups by chance.
The research study procedures include screening for eligibility and study treatment
including evaluations of muscle strength, cardiorespiratory fitness, physical fitness
assessments, body composition including DEXA scans, blood tests, and surveys at study
entry and follow-up visits.
Participation is expected to last about 4 months for the Exercise Group (PARE) and 9
months for the Waitlist Control Group.
It is expected about 30 people with take part in this research study.
Dana-Farber Cancer Institute is supporting this research study by providing funding
through the Population Sciences Team Science Concept program.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Over 18 years old.
- All patients will have a diagnosis of multiple myeloma, referral to DFCI transplant
team, and assigned to the autologous transplantation waiting list for a first
transplant.
- Planning to receive autologous stem cell transplant after 8 weeks with or without
concurrent neoadjuvant treatments at Dana-Farber Cancer Institute.
- Medical clearance to perform moderate-vigorous intensity aerobic and resistance
exercise intervention and fitness testing by their treating physician or a certified
clinical exercise physiologist.
- Speak English.
- Currently participate in less than or equal to 60 minutes of structured
moderate-vigorous intensity exercise/week.
- Willing to travel to Dana-Farber Cancer Institute for necessary data collection.
- Ability to understand and the willingness to sign a written informed consent
document.
- The effects of exercise on the developing fetus are unknown. For this reason, women
of child-bearing potential must agree to undergo a pregnancy test and to use
adequate contraception (hormonal or barrier method of birth control or abstinence)
prior to study entry and for six months following duration of study participation.
Should a woman become pregnant or suspect that she is pregnant while participating
on the trial, she should inform her treating physician immediately.
Exclusion Criteria:
- History of unstable angina, abnormal resting ECG and/or unstable angina or a heart
attack in the previous month to allow safe completion of the cardiopulmonary
exercise test (CPET) or VO2peak test.
- Patients with known spinal instability, spinal cord compression or neurological
deficits or contraindications that preclude exercise.
- Those who have had recent (within six weeks) spinal surgery or other intervention
surgery for pathological fractures.
- Those deemed unsuitable to partake by the transplant or study team.
- Patients at high-risk of impending pathologic fracture of a weight-bearing bone
(including spine, hip/femur and humerus) as determined by physician.
- Unable or unwilling to undertake an exercise program on a regular basis.
- Pre-existing musculoskeletal or cardiorespiratory disease, or metabolic diseases
that could exacerbate with exercise, in addition to other conditions deemed unsafe
by physician.
- Patients with other active malignancies requiring active therapy.
- Participate in more than 60 minutes of structured moderate to vigorous intensity
exercise/week.
- Unable to travel to Dana-Farber Cancer Institute for necessary data collection.
- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Dieli-Conwright, PhD, MPH
Phone:
617-632-3800
Email:
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Investigator:
Last name:
Christina Dieli-Conwright, PhD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Dieli-Conwright
Email:
christinam_dieli-conwright@dfci.harvard.edu
Start date:
June 29, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05706766
