Exercise's effects on complications from corticosteroids in GVHD patients
Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
This study is testing whether a home exercise program can help people with Graft-Versus-Host Disease feel better and improve their health after a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05236062 on ClinicalTrials.gov |
What this trial studies
This research examines the feasibility of a home-based aerobic and resistance exercise program for patients diagnosed with acute or chronic Graft-Versus-Host Disease (GVHD) following an allogeneic stem cell transplant. Participants will be randomly assigned to either the exercise group or an attention control group that performs stretching exercises. The study aims to assess improvements in glycemic control, body composition, physical fitness, and patient-reported outcomes over a 6-month period. A total of 36 participants will undergo testing visits that include blood draws and body composition scans.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old, newly diagnosed with acute or chronic GVHD, and starting corticosteroids post-transplant.
Not a fit: Patients with pre-existing musculoskeletal or cardiorespiratory conditions may not benefit from this exercise intervention.
Why it matters
Potential benefit: If successful, this study could enhance physical fitness and overall health outcomes for patients suffering from GVHD.
How similar studies have performed: While this specific approach is novel, similar studies have shown that exercise can improve outcomes in various patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years old; children under the age of 18 will be excluded due to rarity of disease * Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of .20 mg/kg or greater for the first time since transplant * Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute * Physician's clearance to participate in moderate-vigorous intensity exercise * Speak English * Currently participate in less than 60 minutes of structured 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. Exclusion Criteria: * Have a plan for hospital admission within the next 13 weeks at the time of recruitment * If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible * Pre-existing musculoskeletal or cardiorespiratory conditions * Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease * Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy * Patients with other active malignancies * Participate in more than 60 minutes of structured 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, PhD, MPH
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.