Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Multiple Myeloma Clinical Trial

Official title:

Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation: The PROTECT Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706766
• Other study ID #: 22-403
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: Dana-Farber Cancer Institute
• Contact: Christina Dieli-Conwright, PhD, MPH
• Phone: 617-582-8321
• Email: christinam_dieli-conwright[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Stem Cell Transplant Complications

Intervention

Behavioral:
• PARE
Aerobic and resistance exercise program via Zoom platform.
• Waitlist Control Group
Normal Activities.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Muscular Strength	The primary analysis is a mean difference in percent change between the intervention (PARE) and the control (Waitlist) groups in lower leg muscle strength measured through leg press.	Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
Secondary	Difference in Physical Capacity	Physical capacity includes physical function and cardiorespiratory fitness which are measured through the Short Physical Performance Battery (SPPB) protocol and a maximal oxygen uptake (VO2 max) test, respectively. Differences in physical capacity across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.	up to 9 months
Secondary	Difference in Patient Reported Outcomes	Patient reported outcomes, including fatigue and quality of life, are assessed through validated questionnaires. Differences in patient reported outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.	up to 9 months
Secondary	Difference in Cardiometabolic Health Outcomes	Cardiometabolic health outcomes, including biomarkers of metabolic syndrome and body composition will be assessed through blood draws and dual-energy X-ray absorptiometry (DEXA), validated and safe measures. Differences in cardiometabolic health outcomes across the intervention (PARE) and the control (Waitlist) groups will be assessed using standard statistical techniques of Wilcoxon tests, generalized linear mixed-effects model for longitudinal measurements, proportions and corresponding 95% exact confidence interval.	up to 9 months