Hematopoietic cell transplantation (HCT) reduces physical function and muscle mass and
increases fatigue. Neuromuscular electrical stimulation (NMES), when used as a
stand-alone intervention, improves muscle strength and muscle mass in non-cancer patients
with chronic obstructive pulmonary disease and chronic heart failure. The use of NMES to
combat disuse atrophy and functional decline may be particularly useful in the HCT
setting as patients undergo intensive preparatory chemotherapy and often experience
symptoms including severe fatigue that leave them inactive or isolated for extended time
periods surrounding the transplant. However, its use in the setting of cancer has not
been well-established. This proposal will contribute to developing strategies toward
optimizing the safety and outcomes associated with HCT in Veterans with hematologic
malignancies. The overall goals of this study are to assess 1) the efficacy of an NMES vs
Sham intervention on HCT-induced reductions in physical function and muscle mass and
worsening of patient-reported fatigue and QOL and 2) the association between physical
function and prolonged recovery of patient-reported fatigue and QOL. The investigators
hypothesize that 1) NMES will attenuate the acute HCT-induced negative impact on physical
function, body composition, QOL, and fatigue compared to Sham intervention, and 2)
baseline physical function will be a significant predictor of 6-month recovery of
patient-reported fatigue and QOL. Aim 1: To determine the efficacy of NMES vs. Sham for
attenuation of HCT-induced reductions in physical function, muscle mass, and
patient-reported QOL and fatigue in patients undergoing autologous HCT. Patients will be
randomized 1:1 (NMES:Sham) stratified by diagnosis. Physical function, body composition,
QOL, and fatigue will be assessed at baseline (Pre, after admission to the Bone Marrow
Transplant Unit but before initiation of preparatory chemotherapy) and 28 plus or minus 5
days after HCT (Follow-up 1; FU1). The primary outcome will be between-group difference
in 6MWT change at FU1 compared to Pre (N=23/group; 46 total). Secondary outcomes include:
body composition measured by dual-energy x-ray absorptiometry; previously validated
questionnaires (Functional Assessment of Chronic Illness Therapy-Fatigue; Muscle and
Joint Measures) to assess patient-reported fatigue, QOL, symptom burden, and functional
status; standard of care clinical/laboratory data regarding co-morbidities, adverse
events, hospitalizations, treatment history, functional status, and clinical course; and
NMES process measures such as feasibility, acceptability, adherence in number of
sessions, accurate use, duration/intensity, complications, and satisfaction. Aim 2: To
determine predictive ability of baseline 6MWT on delayed recovery of physical function,
QOL, and fatigue, patient-reported outcomes, physical function, and chart review will be
collected 6-months after HCT (FU2). 6MWT at Pre will be used to determine significant
predictors of QOL and fatigue at FU2 (N=46) as assessed by previously validated
questionnaires. Clinical measures extracted from medical charts will include changes from
FU1 to FU2 in standard of care clinical/laboratory data regarding co-morbidities, adverse
events, hospitalizations, functional status, treatment history, disease trajectory, and
survival. Aim 3 (exploratory): To investigate the acute impact of NMES vs. Sham during
HCT on various aspects of physical function and patient-reported QOL for determining
potential endpoints for future clinical trials. Exploratory measures of function (stair
climbing power; muscle strength; sit-to-stand; handgrip strength; peak oxygen
consumption) assessed at Pre and FU1 will be used to determine significant predictors of
exploratory QOL measures (Multidimensional Fatigue Inventory; Short Form-36; European
Organization for Research and Treatment of Cancer QOL Questionnaire) assessed at FU2.