Individually tailored whole-body vibration training to reduce symptoms of chemotherapy-induced peripheral neuropathy: study protocol of a randomised controlled trial-VANISH.
Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic Agents
/ adverse effects
Exercise
Exercise Therapy
Humans
Middle Aged
Musculoskeletal System
/ pathology
Neoplasms
/ drug therapy
Nervous System
/ pathology
Neurotoxicity Syndromes
/ etiology
Peripheral Nervous System Diseases
/ chemically induced
Quality of Life
Randomized Controlled Trials as Topic
Research Design
Vibration
Young Adult
cancer survivors
cancer therapy
exercise
motor performance
neuromuscular
neurotoxic agents
physical activity
quality of life
reflex activity
sensory deficits
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
24 04 2019
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
e024467Informations 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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