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

NCT03032718 | Unknown

• 1 other identifier: 2016-01527
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Compound muscle action potentials (CMAP)

  Baseline

• Distal motor latency

  Baseline

• Nerve conduction velocity

  Baseline

• Sensory nerve action potentials (SNAPs)

  Baseline

• Peripheral deep sensitivity

  Change over the course of the study, from baseline to post 12-week intervention to post 12-week follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Whole-body vibration training BEHAVIORAL

Whole-body vibration exercise

Intervention

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Basel: lead
• German Sport University, Cologne: collaborator
• University Hospital of Cologne: collaborator
• University of Freiburg: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University of Basel

Basel, 4052, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 31023750 DERIVED

Study Officials

• Fiona Streckmann, PhD

  University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Faude, PhD

CONTACT

0041 61 2074735; oliver.faude@unibas.ch

Fiona Streckmann, PhD

CONTACT

0041 61 2074713; fiona.streckmann@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding against study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head Exercise and Movement Science

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: March 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)