Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
24 04 2019
Historique:
entrez: 27 4 2019
pubmed: 27 4 2019
medline: 14 4 2020
Statut: epublish

Résumé

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. 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. 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. NCT03032718.

Identifiants

pubmed: 31023750
pii: bmjopen-2018-024467
doi: 10.1136/bmjopen-2018-024467
pmc: PMC6501973
doi:

Substances chimiques

Antineoplastic Agents 0

Banques de données

ClinicalTrials.gov
['NCT03032718']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e024467

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Fiona Streckmann (F)

Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.
Institute of Cardiovascular Research and Sport Medicine, German Sport University, Cologne, Germany.
Department of Oncology, University Hospital, Basel, Switzerland.

Viviane Hess (V)

Department of Oncology, University Hospital, Basel, Switzerland.

Wilhelm Bloch (W)

Institute of Cardiovascular Research and Sport Medicine, German Sport University, Cologne, Germany.

Bernhard F Décard (BF)

Department of Neurology, University Hospital, Basel, Switzerland.

Ramona Ritzmann (R)

Department of Sport and Sport Science, University of Freiburg, Freiburg i.Br., Germany.

Helmar C Lehmann (HC)

Department of Neurology, University Hospital, Cologne, Germany.

Maryam Balke (M)

Neurological Day Clinic (NTC) and Department of Early Neurological and Interdisciplinary Rehabilitation, St. Marien-Hospital, Cologne, Germany.

Christina Koliamitra (C)

Institute of Cardiovascular Research and Sport Medicine, German Sport University, Cologne, Germany.

Vanessa Oschwald (V)

Institute of Cardiovascular Research and Sport Medicine, German Sport University, Cologne, Germany.

Thomas Elter (T)

Department of Oncology, University Hospital, Cologne, Germany.

Lukas Zahner (L)

Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.

Lars Donath (L)

Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.
Department of Intervention Research in Exercise Training, German Sports University, Cologne, Germany.

Ralf Roth (R)

Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.

Oliver Faude (O)

Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.

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