Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy

NCT03467087 | Completed

• 1 other identifier: EMS-ICT-001
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Electric Stimulation Therapy

Keywords

Stem cell transplantation; Chemotherapy; Rehabilitation; Electrical muscle stimulation

Outcome Measures

Primary Outcomes (2)

• Occurence of adverse events caused by EMS

  Possible adverse events: bleeding events (defined according to the WHO Bleeding Scale ), arrhythmias, CK elevation, skin irritation

  through study completion, an average of 30 days

• Feasibility of self administered EMS

  Percentage of patients able to complete at least 2/3 of the pre-set training time

  At the time of discharge of every patients, after an average of 30 days

Secondary Outcomes (4)

• Physical performance as assessed by the 6 minute walking distance

  At the time of discharge of every patients, after an average of 30 days

• Physical performance as assessed by the Short Physical Performance Battery

  At the time of discharge of every patients, after an average of 30 days

• Psychological performance as assessed by the Multidimensional Fatigue Inventory

  At the time of discharge of every patients, after an average of 30 days

• Psychological performance as assessed by the EORTC QoL 30 questionnaire

  At the time of discharge of every patients, after an average of 30 days

Study Arms (1)

Electrical muscle stimulation

EXPERIMENTAL

Electrical muscle stimulation is administered on both thighs and upper arms using a Myopuls 2000D device. Pre-set training time is 30 minutes per day (15 minutes for thighs and 15 minutes for upper arms) for at least 5 days a week.

Device: Myopuls 2000D

Interventions

Myopuls 2000D DEVICE

Device: Myopuls 2000D (Curatec Services GmBH, 47443 Moers, Germany)

Electrical muscle stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Related Publications (8)

• Wiskemann J, Kleindienst N, Kuehl R, Dreger P, Schwerdtfeger R, Bohus M. Effects of physical exercise on survival after allogeneic stem cell transplantation. Int J Cancer. 2015 Dec 1;137(11):2749-56. doi: 10.1002/ijc.29633. Epub 2015 Jun 19.

  PMID: 26061092 BACKGROUND

• Wiskemann J, Huber G. Physical exercise as adjuvant therapy for patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Feb;41(4):321-9. doi: 10.1038/sj.bmt.1705917. Epub 2007 Nov 19.

  PMID: 18026154 BACKGROUND

• Takekiyo T, Dozono K, Mitsuishi T, Murayama Y, Maeda A, Nakano N, Kubota A, Tokunaga M, Takeuchi S, Takatsuka Y, Utsunomiya A. Effect of exercise therapy on muscle mass and physical functioning in patients undergoing allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2015 Apr;23(4):985-92. doi: 10.1007/s00520-014-2425-7. Epub 2014 Sep 27.

  PMID: 25256376 BACKGROUND

• Dobsak P, Novakova M, Fiser B, Siegelova J, Balcarkova P, Spinarova L, Vitovec J, Minami N, Nagasaka M, Kohzuki M, Yambe T, Imachi K, Nitta S, Eicher JC, Wolf JE. Electrical stimulation of skeletal muscles. An alternative to aerobic exercise training in patients with chronic heart failure? Int Heart J. 2006 May;47(3):441-53. doi: 10.1536/ihj.47.441.

  PMID: 16823250 BACKGROUND

• Nuhr MJ, Pette D, Berger R, Quittan M, Crevenna R, Huelsman M, Wiesinger GF, Moser P, Fialka-Moser V, Pacher R. Beneficial effects of chronic low-frequency stimulation of thigh muscles in patients with advanced chronic heart failure. Eur Heart J. 2004 Jan;25(2):136-43. doi: 10.1016/j.ehj.2003.09.027.

  PMID: 14720530 BACKGROUND

• Kern H, Barberi L, Lofler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014.

  PMID: 25104935 BACKGROUND

• Windholz T, Swanson T, Vanderbyl BL, Jagoe RT. The feasibility and acceptability of neuromuscular electrical stimulation to improve exercise performance in patients with advanced cancer: a pilot study. BMC Palliat Care. 2014 May 1;13:23. doi: 10.1186/1472-684X-13-23. eCollection 2014.

  PMID: 24808760 BACKGROUND

• Bewarder M, Klostermann A, Ahlgrimm M, Bittenbring JT, Pfreundschuh M, Wagenpfeil S, Kaddu-Mulindwa D. Safety and feasibility of electrical muscle stimulation in patients undergoing autologous and allogeneic stem cell transplantation or intensive chemotherapy. Support Care Cancer. 2019 Mar;27(3):1013-1020. doi: 10.1007/s00520-018-4390-z. Epub 2018 Aug 9.

  PMID: 30094730 DERIVED

Study Officials

• Moritz Bewarder, M.D.

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

• Dominic Kaddu-Mulindwa, M.D.

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 15, 2018
• Study Start: February 3, 2016
• Primary Completion: February 16, 2017
• Study Completion: March 16, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share