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Exercise for Graft-versus-Host Disease (RESTART Trial)

N/A

Recruiting

Led By Christina Dieli-Conwright

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of 1 mg/kg or greater for the first time since transplant

Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute

Must not have

Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease

Pre-existing musculoskeletal or cardiorespiratory conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study if it's possible to do aerobic and resistance exercises for people with GVHD.

Who is the study for?

This trial is for adults over 18 who've had an allogeneic stem cell transplant at Dana-Farber Cancer Institute, are newly diagnosed with acute or chronic GVHD, and starting high-dose corticosteroids. They should do less than 60 minutes of structured exercise per week, be able to travel to the institute for data collection, have physician's clearance for moderate-vigorous exercise, and not be on other treatments.

What is being tested?

The RESTART Trial is testing if a home-based aerobic and resistance exercise program can reduce complications from corticosteroids in patients with GVHD compared to a control group doing stretching exercises. Participants will either follow the exercise regimen or the attention control stretching program.

What are the potential side effects?

Since this trial involves physical exercise programs rather than medication, side effects may include typical risks associated with new workout routines such as muscle soreness or strain. The exact side effects will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am newly diagnosed with GVHD and starting high-dose corticosteroids for the first time since my transplant.

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I had a stem cell transplant from a donor at Dana-Farber Cancer Institute.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses like infections or diabetes.

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I have a condition affecting my muscles, bones, heart, or lungs.

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I have another active cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients completing the exercise intervention sessions

Secondary study objectives

Body Composition

Cardiopulmonary Fitness

Glycemic control level

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Exercise GroupExperimental Treatment1 Intervention

Home-based, virtually supervised via Zoom, 3x weekly for 12-weeks aerobic and resistance exercise program Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).

Group II: Attention control GroupExperimental Treatment1 Intervention

Home-based, 12-week stretching program only with participants asked not to change their activity behavior. Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention control

2013

Completed Phase 2

~2510

Exercise

2016

Completed Phase 1

~820