Status:
TERMINATED
Studying Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 treatmen...
Detailed Description
PRIMARY OBJECTIVE: I. To perform a pilot study to estimate the change in six physical and functional tests over time in patients with suspected acute graft-versus-host disease (GVHD) who have been in...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04521777
Start Date
October 1 2015
End Date
March 18 2021
Last Update
April 20 2021
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030