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

Acute Graft Versus Host Disease Clinical Trial

Official title:

Pilot Study Evaluating Changes in Physical Function Measures in Stem Cell Transplant Patients at Risk for Steroid Myopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04521777
• Other study ID #: 2015-0141
• Secondary ID: NCI-2020-0546020
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: March 18, 2021

Study information

• Verified date: March 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: March 18, 2021
• Est. primary completion date: May 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Behavioral:
• Exercise Intervention
Participate in an 8-week home-based strengthening and walking program

Other:
• Physical Performance Testing
Complete a physical function test
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minutes Walk Test	6 minute walk test (measured in meters) was conducted on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0, and Day 56 minus Day 0.	Baseline, Day 14, Day 28 and Day 56
Primary	5 Times Sit to Stand (5xSTS)	5xSTS was measured in seconds on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.	Baseline, Day 14, Day 28 and Day 56
Primary	Brooke Scale for Myopathy	Brooke Scale for myopathy (a score from 0 to 6, with 6 being the best score with full range of motion of the arms) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0	Baseline, Day 14, Day 28 and Day 56
Primary	Modified Adult Myopathy Assessment Tool	The modified Adult Myopathy Assessment Tool assigns a numerical score to a series of physical tasks (arm raise [0 to 3], sustained arm raise [0 to 4], single sit-to-stand [0 to 3], sustained hip flexion [0 to 4], and sustained knee extension [0 to 4]). The total score of all test components (0 to 18) is reported, with 18 as the highest score for muscle function and endurance.	Baseline, Day 14, Day 28 and Day 56
Primary	Knee Extensors Strength	Knee Extensors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median change for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.	Baseline, Day 14, Day 28 and Day 56
Primary	Hip Flexors Strength	Hip Flexors Strength (in pounds) was measured on Baseline, Day 14, Day 28 and Day 56 and measured the median changes for Day 14 minus Day 0, Day 28 minus Day 0 and Day 56 minus Day 0.	Baseline, Day 14, Day 28 and Day 56

External Links

•   University of Texas MD Anderson Cancer Center Official Website