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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

— VANISH  

Official title:

Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03032718
• Other study ID #: 2016-01527
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2017
• Last updated: March 8, 2017
• Start date: March 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: March 2017
• Source: University of Basel
• Contact: Oliver Faude, PhD
• Phone: 0041 61 2074735
• Email: oliver.faude[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• Whole-body vibration training
Whole-body vibration exercise

Locations

Country	Name	City	State
Switzerland	University of Basel	Basel

Sponsors (5)

Lead Sponsor	Collaborator
University of Basel	German Sport University, Cologne, University Hospital of Cologne, University Hospital, Basel, Switzerland, University of Freiburg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]	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".	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Compound muscle action potentials (CMAP)	obtained from the tibial and peroneal nerve	Baseline
Secondary	Distal motor latency	obtained from the tibial and peroneal nerve	Baseline
Secondary	Nerve conduction velocity	obtained from the tibial and peroneal nerve	Baseline
Secondary	Sensory nerve action potentials (SNAPs)	recorded from the lateral malleolus with surface electrodes	Baseline
Secondary	Peripheral deep sensitivity	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	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Reflex action	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).	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Sense of position	This test examines whether patients can recognize a change of position in their first toe, with their eyes closed.	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Perception of touch	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.	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Muscular strength	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).	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	EMG recordings	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.	1 week (first 2 training sessions)
Secondary	CIPN-related pain	Visual analogue scale (VAS) in order to assess neuropathic pain as well as the dysesthesias	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Postural control	Center of pressure during upright static and dynamic stance	Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Quality of life - questionnaire		Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary	Physical activity questionnaire		Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up