Clinical trial NCT05706766: Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Official title: Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Stem Cell Transplant Complications
Keywords: Multiple Myeloma
Autologous Stem Cell Transplant
Aerobic Exercise Program
Resistance Exercise Program
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Difference in Muscular Strength
timeFrame: Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
Secondary outcomes:
measure: Difference in Physical Capacity
timeFrame: up to 9 months
measure: Difference in Patient Reported Outcomes
timeFrame: up to 9 months
measure: Difference in Cardiometabolic Health Outcomes
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: