Autologous Hematopoietic Stem Cell TransplantNCT04364256
Muscle Stimulation for Physical Function During Stem Cell Transplant
A study testing RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) in people with Autologous Hematopoietic Stem Cell Transplant, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Hematopoietic Stem Cell Transplant
- What is being tested?
- RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adequate cognitive and language ability to provide consent
- Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
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.
- Being tested
- RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)
- Keywords
- neuromuscular electrical stimulation, physical function, hematologic cancer, muscle wasting, multiple myeloma, lymphoma, Hematopoietic Stem Cell Transplant, cancer cachexia, cancer rehabilitation
- Medical subject headings
- Hematologic Neoplasms, Muscular Atrophy, Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)Device
Also called NMES, e-stim
Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012
| Study group | Role | What they receive |
|---|---|---|
| Active NMES | Active comparator | asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction. Receives: Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) |
| Sham NMES | Sham comparator | The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction. Receives: Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test
Manual and mobile application assessment
Measured: change from before to 1month after transplant
Secondary outcomes (12)
Patient-reported Fatigue
Anderson Symptom Assessment Scale (range 0-10 where 10 is maximum fatigue)
Measured: change from before to 1month after transplant
Lean Body Mass
dual energy fan-beam x-ray absorptiometry; bioelectrical impedance
Measured: change from before to 1month after transplant
Physical Activity
triaxial accelerometry
Measured: change from before to 1month after transplant
NMES adherence
Number of sessions completed out of total sessions
Measured: 1month after transplant
Muscle Damage (safety)
plasma creatine kinase
Measured: change from before to 2 weeks after intervention initiation
Muscle Damage (safety)
plasma creatine kinase
Measured: change from before to 4 weeks after intervention initiation
Muscle Damage (safety)
plasma creatine kinase
Measured: change from before to 6 weeks after intervention initiation
Muscle Damage (safety)
plasma creatine kinase
Measured: change from before to 8 weeks after intervention initiation
Muscle Damage (safety)
plasma creatine kinase
Measured: change from before to 1month after transplant
6-Minute Walk Test
Mobile application assessment
Measured: change from before to 6 months after transplant
Patient-reported Fatigue
Anderson Symptom Assessment Scale (range 0-10 where 10 is maximum fatigue)
Measured: change from before to 6 months after transplant
Physical Activity
triaxial accelerometry
Measured: change from before to 6 months after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start14 May 2021
- Primary completion30 Sep 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autologous Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neuromuscular electrical stimulation (active vs sham signal)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lindsey J Anderson, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364256
- Sponsor's protocol ID
- F3245-W
- Other IDs
- IK2RX003245-03
- Status last verified
- Dec 2025
- First submitted
- 20 Apr 2020
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Anderson LJ, Paulsen L, Miranda G, Syrjala KL, Graf SA, Chauncey TR, Garcia JM. Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation: Study protocol. PLoS One. 2024 May 10;19(5):e0302970. doi: 10.1371/journal.pone.0302970. eCollection 2024.
PubMed 38728244
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04364256
- Acronym / sponsor ID
- F3245-W
- Keywords
- neuromuscular electrical stimulation, physical function, hematologic cancer, muscle wasting, multiple myeloma, lymphoma, Hematopoietic Stem Cell Transplant, cancer cachexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Neuromuscular electrical stimulation (active vs sham signal)
| Arm | Type | Receives |
|---|---|---|
| Active NMES | Active comparator | Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction. |
| Sham NMES | Sham comparator | Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adequate cognitive and language ability to provide consent
- Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)Also: NMES, e-stimActive or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012 | Device | Active NMES, Sham NMES |
Primary outcome
6-Minute Walk Test
Time frame: change from before to 1month after transplant
Manual and mobile application assessment
12 secondary outcomes
Patient-reported Fatigue
Time frame: change from before to 1month after transplant
Lean Body Mass
Time frame: change from before to 1month after transplant
Physical Activity
Time frame: change from before to 1month after transplant
NMES adherence
Time frame: 1month after transplant
Muscle Damage (safety)
Time frame: change from before to 2 weeks after intervention initiation
Muscle Damage (safety)
Time frame: change from before to 4 weeks after intervention initiation
Muscle Damage (safety)
Time frame: change from before to 6 weeks after intervention initiation
Muscle Damage (safety)
Time frame: change from before to 8 weeks after intervention initiation
Muscle Damage (safety)
Time frame: change from before to 1month after transplant
6-Minute Walk Test
Time frame: change from before to 6 months after transplant
Patient-reported Fatigue
Time frame: change from before to 6 months after transplant
Physical Activity
Time frame: change from before to 6 months after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 38728244Anderson LJ, Paulsen L, Miranda G, Syrjala KL, Graf SA, Chauncey TR, Garcia JM. Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation: Study protocol. PLoS One. 2024 May 10;19(5):e0302970. doi: 10.1371/journal.pone.0302970. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey J Anderson, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) in people with Autologous Hematopoietic Stem Cell Transplant, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (time frame: change from before to 1month after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.