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

Primary Purpose

Multiple Myeloma, Stem Cell Transplant Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PARE
Waitlist Control Group
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Multiple Myeloma, Autologous Stem Cell Transplant, Aerobic Exercise Program, Resistance Exercise Program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting
  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Group (PARE)

Waitlist Control Group

Arm Description

Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). Questionnaires and surveys.

Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: 8 weeks of continuing with normal daily activities. Option to participate in PARE exercise program after study completion. 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 20, 2023
Last Updated
August 10, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05706766
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Stem Cell Transplant Complications
Keywords
Multiple Myeloma, Autologous Stem Cell Transplant, Aerobic Exercise Program, Resistance Exercise Program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group (PARE)
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). Questionnaires and surveys.
Arm Title
Waitlist Control Group
Arm Type
Active Comparator
Arm Description
Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: 8 weeks of continuing with normal daily activities. Option to participate in PARE exercise program after study completion. 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.
Intervention Type
Behavioral
Intervention Name(s)
PARE
Other Intervention Name(s)
Prehabilitation Aerobic and Resistance Exercise training program
Intervention Description
Aerobic and resistance exercise program via Zoom platform.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist Control Group
Intervention Description
Normal Activities.
Primary Outcome Measure Information:
Title
Difference in Muscular Strength
Description
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.
Time Frame
Pre-transplant (Week 9, post-intervention), and post-transplant (Week 14-15, 30 Day Post-ASCT Follow-Up)
Secondary Outcome Measure Information:
Title
Difference in Physical Capacity
Description
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.
Time Frame
up to 9 months
Title
Difference in Patient Reported Outcomes
Description
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.
Time Frame
up to 9 months
Title
Difference in Cardiometabolic Health Outcomes
Description
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.
Time Frame
up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
christinam_dieli-conwright@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-632-3800
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright
Email
christinam_dieli-conwright@dfci.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

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