Introduction Chemotherapy-induced peripheral neuropathy (CIPN) is a prevalent and clinically meaningful side effect of cancer treatment. CIPN is induced by neurotoxic agents, causing severe sensory and/or motor deficits, resulting in disability and poor recovery, reducing patients’ quality of life and limiting medical therapy. To date, effective treatment options are lacking. Whole-body vibration (WBV) training can attenuate motor and sensory deficits. We are conducting a two-armed, multicentre, assessor-blinded, randomised controlled trial, to investigate the effects of WBV on relevant symptoms of CIPN and determine the training characteristics.
Methods and analysis In this ongoing study, 44 patients who have completed therapy in the past 3 months, with a neurologically confirmed CIPN are assessed before and after a 12-week intervention and follow-up. The intervention group receives WBV twice a week. Exercises are individually tailored according to the initially determined optimal neuromuscular response. The control group receives care as usual.
Primary endpoint is the patient reported reduction of CIPN-related symptoms (Functional Assessment of Cancer Therapy/Gynaecology Oncology Group—Neurotoxicity). Secondary endpoints are compound muscle action potentials, distal motor latency, conduction velocity, F-waves from the tibial and peroneal nerve, antidromic sensory nerve conduction studies of the sural nerve, normalised electromyographic activity, peripheral deep sensitivity, proprioception, balance, pain, the feasibility of training settings, quality of life and the level of physical activity.
Aim, ethics and dissemination The study was approved by both responsible ethics committees. (1) Our results may contribute to a better understanding of the effects of WBV on motor and sensory functions and (2) may provide information whether WBV at the most effective setting, is feasible for neuropathic patients. (3) Our results may also contribute to improve supportive care in oncology, thereby enhancing quality of life and enabling the optimal medical therapy. All results will be published in international peer-reviewed journals as well as a manual for clinical practice.
Trial registration number NCT03032718
- sensory deficits
- motor performance
- reflex activity
- quality of life
- cancer therapy
- neurotoxic agents
- physical activity
- cancer survivors
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Contributors FS and OF designed the study protocol. VH, BFD, RRi, WB, HCL and TE contributed to the design of the study. FS organises the study in both countries (ie, recruitment, data collection, quality control). FS, VH and TE are responsible for patient recruitment. BFD, HCL and MB are responsible for neurological assessments. RRi, RRo and LD support electromyographic assessment, analysis and interpretation. CK is responsible for the electromyographic assessment and training and VO for patient coordination and organisation in Cologne. FS, LZ, RRo, LD and OF designed the exercise intervention programme. FS, LD and OF conduct the overall data management and organise data preparation. OF and LD analyse the data. FS and OF wrote the present manuscript. All authors revised the study protocol, read and approved the final manuscript. FS is the guarantor.
Funding This study is funded by the ’Research Fund for Junior Researchers' of the University of Basel (DMS2345). FS is partly funded by a grant (grant number 70112048) of the German Cancer Aid (Deutsche Krebshilfe—DKH). The study funders have no influence on study design, collection, management, analysis and interpretation of data, writing of the report and the decision to submit the report for publication. Proofs of ethics approval and funding by email to the editorial office.
Competing interests None declared.
Ethics approval The study was approved by both responsible ethics committees (Basel, Switzerland/Cologne, Germany).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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