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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

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.


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Behavioral: Whole-body vibration training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinding against study arm
Primary Purpose: Treatment
Official Title: Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Whole-body vibration training
Whole-body vibration exercise

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.



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. Compound muscle action potentials (CMAP) [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve

  2. Distal motor latency [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve

  3. Nerve conduction velocity [ Time Frame: Baseline ]
    obtained from the tibial and peroneal nerve

  4. Sensory nerve action potentials (SNAPs) [ Time Frame: Baseline ]
    recorded from the lateral malleolus with surface electrodes

  5. 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

  6. 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).

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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

  12. 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

  13. 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 ]
  14. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032718


Contacts
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Contact: Oliver Faude, PhD 0041 61 2074735 oliver.faude@unibas.ch
Contact: Fiona Streckmann, PhD 0041 61 2074713 fiona.streckmann@unibas.ch

Locations
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Switzerland
University of Basel Recruiting
Basel, Switzerland, 4052
Contact: Fiona Streckmann, PhD       fiona.streckmann@unibas.ch   
Sponsors and Collaborators
University of Basel
German Sport University, Cologne
University Hospital of Cologne
University of Freiburg
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Fiona Streckmann, PhD University of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oliver Faude, Deputy Head Exercise and Movement Science, University of Basel
ClinicalTrials.gov Identifier: NCT03032718     History of Changes
Other Study ID Numbers: 2016-01527
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases