Muscle Stimulation for Physical Function During Stem Cell Transplant

Completed · Not applicable · Has a placebo group

Conditions studied: Autologous Hematopoietic Stem Cell Transplant

In brief

Some blood, bone marrow, and lymphatic (hematologic) cancers such as Hodgkin/Non-Hodgkin lymphomas, chronic lymphocytic leukemia, and multiple myeloma, are over-represented in Veterans due to exposures including Agent Orange and an increased percentage of patients of African American ethnicity. Hematologic transplantation (HCT) is a common treatment for these cancers, but often leads to deconditioning, fatigue, muscle atrophy, and poor quality of life, which are associated with complications such as hospitalization and infection. Despite the significance of these symptoms, there are no approved treatments to prevent/reverse these long-term effects. The cancer itself, side effects of chemotherapy, and sedentary behavior, contribute to these effects. Although exercise before and after HCT has helped reduce these effects, it is inconsistently recommended to patients and most remain sedentary through and after treatment. The investigators are testing an alternative exercise strategy, neuromuscular electrical stimulation, to maintain physical function quality of life after HCT.

Key facts

Study ID

NCT04364256

Run by

VA Office of Research and Development

People needed

46

Starts

2021-05-14

Expected to finish

2025-12-29

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adequate cognitive and language ability to provide consent
• Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT

You may not qualify if…

• active deep vein thrombosis or thrombophlebitis
• untreated hemorrhagic disorders
• concomitant study inclusion in other nutritional or physical exercise interventional trials
• concomitant use of anabolic agents
• rhabdomyolysis or other muscle conditions where NMES is contraindicated
• implanted cardiac device
• baseline patient-reported muscle soreness of 5-6 on the soreness likert scale that is unrelated to recent physical exertion
• history of prior hematologic stem cell transplant
• probable or definitive liver cirrhosis
• reduced renal clearance defined as Stage 4 chronic kidney disease (glomerular filtration rate <45 ml/min/1.73 m2)

Where it is running

• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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