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

Primary Purpose

Acute Graft Versus Host Disease

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

Physical Performance Testing

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Acute Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (exercise intervention)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04521777

First Posted

August 11, 2020

Last Updated

March 25, 2021

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04521777

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Terminated

Why Stopped

Terminated early due to slow accrual

Study Start Date

October 1, 2015 (Actual)

Primary Completion Date

May 8, 2017 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Graft Versus Host Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (exercise intervention)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Participate in an 8-week home-based strengthening and walking program

Intervention Type

Other

Intervention Name(s)

Physical Performance Testing

Other Intervention Name(s)

Physical Fitness Testing, Physical Function Testing

Intervention Description

Complete a physical function test

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

6 Minutes Walk Test

Description

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.

Time Frame