Clinical trial NCT03467087: Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy
Official title: Safety and Feasibility of Electrical Muscle Stimulation in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation or Chemotherapy Requiring Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electric Stimulation Therapy
Keywords: Stem cell transplantation
Chemotherapy
Rehabilitation
Electrical muscle stimulation
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intensive chemotherapy, with or without following autologous or allogeneic stem cell transplantation (HSCT), is often the only curative treatment option for patients with haematological malignancies, leave many survivors physically and psychologically impaired because of side effects, many caused by weeks of immobilisation. Electrical muscle stimulation (EMS) is a proven training tool to improve physical performance in seniors and patients with chronic disease. The investigators therefore intend to evaluate the safety and feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive chemotherapy. To assess feasibility all patients are asked to document training time during hospitalization in an EMS diary.

Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD) and Short Physical Performance Battery (SPPB) as well as psychological performance using the Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1) and when patients are discharged from hospital (T2).

At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are met, patients will receive an EMS device with electrodes and will be instructed on how to use the device. After that, baseline tests using the above mentioned tools will be performed.

EMS will be conducted with a "Myopuls 2000" (Curatec Services GmbH, Moers, Germany) device using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and patients are encouraged to increase the amplitude as much as tolerated. After an initial training session, patients are to use the devices on their own and document their activities in an EMS diary.

Patients are then asked to use EMS throughout their therapy in addition to physical therapy until the day of their discharge when the initially performed tests are repeated.

The investigators hypothesis is, that EMS can be safely applied in patients undergoing intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.


Eligibility criteria: Inclusion Criteria:

* 18 - 80 years of age
* ECOG mperformance status 0-2
* patients undergoing chemotherapy regimens and and expected hospitalization time of \> 14 days

Exclusion Criteria:

* patients with pacemakers and defibrillators
* patients with metallic implants close to stimulation sites
* skin irritations and injuries at the site of electrode placement
* pregnancy
* epilepsy
* patient is physically or mentally unable to administer EMS by him/her -self
* history of ventricular arrhythmias
* peripheral arterial disease
* deep vein thrombosis in the past 3 month
* myocardial infarction or stroke in the past 3 month

Primary outcomes:
measure: Occurence of adverse events caused by EMS
timeFrame: through study completion, an average of 30 days
measure: Feasibility of self administered EMS
timeFrame: At the time of discharge of every patients, after an average of 30 days
Secondary outcomes:
measure: Physical performance as assessed by the 6 minute walking distance
timeFrame: At the time of discharge of every patients, after an average of 30 days
measure: Physical performance as assessed by the Short Physical Performance Battery
timeFrame: At the time of discharge of every patients, after an average of 30 days
measure: Psychological performance as assessed by the Multidimensional Fatigue Inventory
timeFrame: At the time of discharge of every patients, after an average of 30 days
measure: Psychological performance as assessed by the EORTC QoL 30 questionnaire
timeFrame: At the time of discharge of every patients, after an average of 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Saarland
name: Moritz Bewarder, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Dominic Kaddu-Mulindwa, M.D.
role: PRINCIPAL_INVESTIGATOR
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