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Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy (VANISH)

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ClinicalTrials.gov Identifier: NCT03032718
Recruitment Status : Unknown
Verified March 2017 by Oliver Faude, University of Basel.
Recruitment status was:  Recruiting
First Posted : January 26, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
German Sport University, Cologne
University Hospital of Cologne
University of Freiburg
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Oliver Faude, University of Basel

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 9, 2017
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity] [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
It will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. This questionnaire has been validated and is widely applied in clinical practise. It contains eleven items which allow an assessment of the extent of PNP symptoms - from "not at all" to "very much".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Compound muscle action potentials (CMAP) [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve
  • Distal motor latency [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve
  • Nerve conduction velocity [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve
  • Sensory nerve action potentials (SNAPs) [ Time Frame: Baseline ]
    recorded from the lateral malleolus with surface electrodes
  • Peripheral deep sensitivity [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    evaluated with a Rydel-Seiffer tuning fork (128Hz) on a scale from 0 to 8; due to age related neural deconditioning, values ≤4 are pathological for patients ≥ 60years old, while for patients under 60 years old, ≤5 is regarded as pathological
  • Reflex action [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    The Achilles tendon reflex as well as the patellar tendon reflex is assessed with a reflex hammer and graded on a 3 point scale (1=agile, 2=weak, 3=missing).
  • Sense of position [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    This test examines whether patients can recognize a change of position in their first toe, with their eyes closed.
  • Perception of touch [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    The examiner symmetrically strokes the outsides of the patients' legs and feet in order to detect reduced or altered sensation due to demyelination or axonal degeneration.
  • Muscular strength [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    The strength of the leg muscles is assessed by requesting the patient to actively move their legs against the resistance of the examiner's arm. The examiner then grades the strength on a six point scale (0=no activity, 1=visual contraction without motor effect, 2=movement under elimination of gravity, 3=movement under gravity, 4=movement against slight resistance 5=normal force).
  • EMG recordings [ Time Frame: 1 week (first 2 training sessions) ]
    Normalized (to static standing without vibration condition) integrated EMG activity of mm. tibialis anterior, soleus, gastrocnemius (medial head), mm. rectus femoris, vastus medialis, biceps femoris. EMG recordings will be performed using bipolar Ag/AgCl surface electrodes placed over the mm. soleus, gastrocnemius medialis, tibialis anterior, rectus femoris, vastus medialis and biceps femoris of the right leg. A reference electrode will be placed on the patella. To keep interelectrode resistance below 2 kOhm, the skin areas for the electrodes will have to be shaved, degreased and slightly abraded. The EMG signals will then be transmitted to the amplifier (band-pass filter 10 Hz-1 kHz, 1,0009 amplified) via shielded cables and recorded with 4 kHz.
  • CIPN-related pain [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    Visual analogue scale (VAS) in order to assess neuropathic pain as well as the dysesthesias
  • Postural control [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
    Center of pressure during upright static and dynamic stance
  • Quality of life - questionnaire [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
  • Physical activity questionnaire [ Time Frame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy
Official Title  ICMJE Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically meaningful side effect of cancer treatment. It is induced by neurotoxic chemotherapeutic agents, causing severe sensory and/or motor deficits such as pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control, insecure gait, and higher risk of falling. It is associated with significant disability and poor recovery, not only reducing patients' autonomy and quality of life but also limiting medical cancer therapy, which subsequently may affect the clinical outcome and compromise survival. To date, CIPN cannot be prevented and approved and effective treatment options are lacking.

Promising results regarding CIPN have recently been achieved with exercise. Own preliminary work revealed that patients profit from sensorimotor training (SMT), experiencing significant relief from CIPN induced symptoms. In a pilot study we therefore also evaluated whole body vibration training, a further neuromuscular stimulating exercise intervention. Results suggest that whole body vibration (WBV) is not only feasible and safe for neuropathic cancer patients but can attenuate motor and sensory deficits.

We therefore propose a two-armed, multicenter, randomized controlled trial (RCT with a follow-up period), including 44 patients with neurologically confirmed CIPN, in order to evaluate the effects of WBV on the relevant symptoms of CIPN. Primary endpoint is the patient reported reduction of CIPN-related symptoms (FACT-GOG-Ntx). Secondary endpoints will include compound muscle action potentials, distal motor latency, conduction velocity, and F-waves from the tibial and peroneal nerve as well as antidromic sensory nerve conduction studies of the sural nerve, feasibility, non-invasive electromyographic (EMG) activity of mm. tibialis anterior, soleus, gastrocnemius medialis, rectus femoris, vastus medialis and biceps femoris, peripheral deep sensitivity, proprioception, balance control as well as pain, quality of life and the level of physical activity. Patients will be assessed before and after a 12 week intervention and again after 12 weeks of follow-up. Interim tests will be performed 6 weeks into the intervention as well as every 3 weeks during the follow-up.

We hypothesize that individually tailored whole body vibration training will reduce relevant symptoms of CIPN. Our results could contribute to improve supportive care in oncology, thereby enhancing patients' quality of life and coincidentally enabling the optimal medical therapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Blinding against study arm
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy-induced Peripheral Neuropathy
Intervention  ICMJE Behavioral: Whole-body vibration training
Whole-body vibration exercise
Study Arms  ICMJE
  • Experimental: Intervention
    Patients in the intervention group will receive a defined exercise program twice a week in addition to their usual treatment. Training sessions start immediately after randomization and will be supervised by trained sport students. They will take place twice a week, for twelve weeks in specific training rooms designed to meet the needs of oncological patients in the respective centers. The vibration exercises will take place on a side-alternating vibration platform (GalileoTM, Pforzheim, Germany) ®) according to the previously determined optimal (highest neuromuscular response) setting for each individual. Each session will last for about 15 to 30 minutes, leaving sufficient time for regeneration. Training will consist of four vibration exercises, chosen from a standardized pool of exercises with increasing difficulty in order to allow for individual, optimal progression. All sessions will be documented by the supervisor.
    Intervention: Behavioral: Whole-body vibration training
  • No Intervention: Control
    Patients in the control group will receive treatment as usual and will be given the opportunity to participate in the intervention after completion of the study.
Publications * Streckmann F, Hess V, Bloch W, Décard BF, Ritzmann R, Lehmann HC, Balke M, Koliamitra C, Oschwald V, Elter T, Zahner L, Donath L, Roth R, Faude O. Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH. BMJ Open. 2019 Apr 24;9(4):e024467. doi: 10.1136/bmjopen-2018-024467.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • oncological patients with neurologically confirmed CIPN
  • age: 18-80 years
  • performance status of 0-2 according to the toxicity and response criteria of the Eastern Cooperative Oncology Group
  • patients underwent neurotoxic chemotherapy with one of the following agents: Taxanes (docetaxel with a cumulative dose of ≥ 225mg/m2 or paclitaxel with a cumulative dose of ≥ 525mg/m2), Vinca-alkaloids (vincristine with a cumulative dose of ≥ 4.2mg/m2 or vinblastine with a cumulative dose of 24mg/m2), Platinum-derivatives (Oxaliplatin with a cumulative dose of ≥ 510mg/m2, Cisplatinum with a cumulative dose of ≥ 200mg/m2)

Exclusion Criteria:

  • pre-existing neuropathy of other cause (e.g. diabetes)
  • given contraindications for WBV (instable osteolysis, osteosynthesis, acute thrombosis, foot ulcers and a fracture of a lower extremity in the last two years)
  • a myocardial infarction, angina pectoris or heart disease (NYHA III-IV) within the past six months
  • a mental condition or lack of the German language that prevents the understanding of the written informed consent
  • metastases of the central nervous system and epilepsy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032718
Other Study ID Numbers  ICMJE 2016-01527
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oliver Faude, University of Basel
Study Sponsor  ICMJE University of Basel
Collaborators  ICMJE
  • German Sport University, Cologne
  • University Hospital of Cologne
  • University of Freiburg
  • University Hospital, Basel, Switzerland
Investigators  ICMJE
Principal Investigator: Fiona Streckmann, PhD University of Basel
PRS Account University of Basel
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP