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

NCT04521777 | Terminated Results

• 2 other identifiers: 2015-0141NCI-2020-05460
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Supportive care (exercise intervention)

EXPERIMENTAL

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.

Behavioral: Exercise Intervention; Other: Physical Performance Testing; Other: Questionnaire Administration

Interventions

Exercise Intervention BEHAVIORAL

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

Supportive care (exercise intervention)

Physical Performance Testing OTHER

Complete a physical function test

Also known as: Physical Fitness Testing, Physical Function Testing

Supportive care (exercise intervention)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (exercise intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ngo-Huang A, Yadav R, Bansal S, Williams J, Wu J, Fu JB, Alousi AM, Bruera E. An Exploratory Study on Physical Function in Stem Cell Transplant Patients Undergoing Corticosteroid Treatment for Acute Graft-Versus-Host-Disease. Am J Phys Med Rehabil. 2021 Apr 1;100(4):402-406. doi: 10.1097/PHM.0000000000001660.

  PMID: 33278131 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Results Point of Contact

• Title: An T Ngo-Huang, Assistant Professor, Rehabilitation Medicine
• Organization: UT MD Anderson Cancer Center

ango2@mdanderson.org

(713) 745-2327

Study Officials

• An T Ngo-Huang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 21, 2020
• Study Start: October 1, 2015
• Primary Completion: May 8, 2017
• Study Completion: March 18, 2021
• Last Updated: April 20, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-03

Locations

US (1)