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

March 25, 2021 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (exercise intervention)
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.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Exercise Intervention
Participate in an 8-week home-based strengthening and walking program
Other: Physical Performance Testing
Complete a physical function test
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walk Test
Time Frame: Baseline, Day 14, Day 28 and Day 56
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
5 Times Sit to Stand (5xSTS)
Time Frame: Baseline, Day 14, Day 28 and Day 56
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
Brooke Scale for Myopathy
Time Frame: Baseline, Day 14, Day 28 and Day 56
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
Modified Adult Myopathy Assessment Tool
Time Frame: Baseline, Day 14, Day 28 and Day 56
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
Knee Extensors Strength
Time Frame: Baseline, Day 14, Day 28 and Day 56
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
Hip Flexors Strength
Time Frame: Baseline, Day 14, Day 28 and Day 56
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: An T Ngo-Huang, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 8, 2017

Study Completion (Actual)

March 18, 2021

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0141 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-05460 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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