Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation

Overview

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.
SparkCures ID 1892
Enrollment 46 Patients
Tags
  • Closed Label (Masked)
  • Randomization
Trial Sponsors
  • U.S. Department of Veterans Affair
NCT Identifier

NCT04364256

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

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

Exclusion Criteria:

* 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)

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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