Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

Stopped early · Not applicable

Conditions studied: Acute Graft Versus Host Disease

In brief

This trial investigates the changes in physical and functional tests over time in patients with suspected acute graft versus host disease (from a hematologic stem cell transplant) who started treatment with corticosteroids. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Steroids are used to treat suspected graft-versus-host disease. Steroid myopathy (muscle weakness and fatigue) is a significant side effect of high dose steroid therapy, and can impair activities of daily of life. The goal of this trial is to learn how patients' physical activities and functions change over time while on GVHD-steroid treatment.

Key facts

Study ID

NCT04521777

Run by

M.D. Anderson Cancer Center

People needed

24

Starts

2015-10-01

Expected to finish

2021-03-18

Last updated by the study team

2021-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants are willing and able to give written informed consent and to comply with all of the study visits and procedures
• Age >= 55 years, or with a Sorror co-morbidity index of >= 3
• Post allogenic hematopoietic stem cell transplantation using bone marrow, peripheral blood or cord blood; or after pre planned donor lymphocyte infusion
• Presumptive diagnosis of acute GVHD necessitating high-dose corticosteroid treatment (with an approximate starting dose of methylprednisolone equivalent of 2 mg/kg/day)
• Within 5 days of receiving corticosteroid treatment
• ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 or equivalent Karnofsky score of 60 or higher
• The patient is referred to the study by their stem cell transplant attending physician

You may not qualify if…

• Non-English speaking
• Underlying unstable cardiac or pulmonary disease in the opinion of the investigator that limits participant involvement in exercise
• Has a pre-transplant echocardiogram with ejection fraction < 45%
• Requires supplemental oxygen to maintain oxygen (O2) saturation > 92%
• Musculoskeletal injury that precludes participation in an exercise program
• Inability to participate in a structured exercise program
• Patients for whom the physician feels is unsafe for an exercise program
• Platelets equal to or less than 10,000 or evidence of active bleeding
• Patients who are unable to understand or follow through with the exercise program

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.