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

M.D. Anderson Cancer Center

Status

Terminated

Conditions

Acute Graft Versus Host Disease

Treatments

Other: Physical Performance Testing

Behavioral: Exercise Intervention

Other: Questionnaire Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04521777

NCI-2020-05460 (Registry Identifier)

2015-0141 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 initiated on treatment with corticosteroids.

SECONDARY OBJECTIVES:

I. To describe and potentially define steroid myopathy by following the patterns of the muscle loss and functional impairment in this population of patients.

II. To follow steroid myopathy and describe its incidence, its severity, and the impact on non-relapse mortality in a homogeneous population of patients with suspected acute graft-versus-host disease (GVHD) who have been initiated on treatment with corticosteroids at a quaternary institution in the inpatient and outpatient setting.

III. To estimate the adherence to an intermittently supervised exercise program in hematopoietic stem cell transplantation (HSCT) patients who are at risk of developing steroid myopathy.

OUTLINE:

Patients complete a physical function test over 15 minutes at baseline, and at days 14, 28, and 56. Patients also participate in an 8-week home-based strengthening and walking program consisting of a strengthening/resistance program for 30 minutes, 3 times a week, and walking program for 20-30 minutes at least 3 times a week.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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