Clinical trial NCT03032718: Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy
Official title: Effects of Individually Tailored Whole-body Vibration Training on the Symptoms of Chemotherapy-induced Peripheral Neuropathy: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
name: University Hospital of Cologne
name: University of Freiburg
name: University Hospital, Basel, Switzerland
First posted: 2017-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: FACT/GOG-Ntx questionnaire [Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity]
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Secondary outcomes:
measure: Compound muscle action potentials (CMAP)
timeFrame: Baseline
measure: Distal motor latency
timeFrame: Baseline
measure: Nerve conduction velocity
timeFrame: Baseline
measure: Sensory nerve action potentials (SNAPs)
timeFrame: Baseline
measure: Peripheral deep sensitivity
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Reflex action
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Sense of position
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Perception of touch
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Muscular strength
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: EMG recordings
timeFrame: 1 week (first 2 training sessions)
measure: CIPN-related pain
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Postural control
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Quality of life - questionnaire
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
measure: Physical activity questionnaire
timeFrame: Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
affiliation: University of Basel
name: Fiona Streckmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Streckmann F, Hess V, Bloch W, Decard 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.