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Support Care Cancer. 2017 Jan;25(1):195-204. Epub 2016 Sep 9.

A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN).

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The University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.
Endeavour College of Natural Health, Brisbane, 4006, Australia.
Medical Oncology Group of Australia, Clinical Oncology Society of Australia, Queensland Clinical Oncology Group, Brisbane, 4000, Australia.
Neurology Fellow at Queensland Health, Department of Neurology, Ned Hanlon Building, RBWH, Herston, Brisbane, 4006, Australia.
The University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.
The University of Sydney, Sydney Medical School, Sydney, 2006, Australia.
Medlab Clinical Ltd, Sydney, 2015, Australia.



Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect resulting from neurotoxic chemotherapeutic agents. This study aimed to assess the efficacy and safety of an oral B group vitamin compared to placebo, in preventing the incidence of CIPN in cancer patients undergoing neurotoxic chemotherapy.


A pilot, randomised, placebo-controlled trial was conducted. Newly diagnosed cancer patients prescribed with taxanes, oxaliplatin or vincristine were invited to participate. A total of 71 participants (female 68 %, male 32 %) were enrolled into the study and randomised to the B group vitamin (n = 38) arm or placebo (n = 33). The data from 47 participants were eligible for analysis (B group vitamins n = 27, placebo n = 22). The primary outcome measure was the total neuropathy score assessed by an independent neurologist. Secondary outcome measures included serum vitamin B levels, quality of life, pain inventory and the patient neurotoxicity questionnaires. Outcome measures were conducted at baseline, 12, 24 and 36 weeks.


The total neuropathy score (TNS) demonstrated that a B group vitamin did not significantly reduce the incidence of CIPN compared to placebo (p = 0.73). Statistical significance was achieved for patient perceived sensory peripheral neuropathy (12 weeks p = 0.03; 24 weeks p = 0.005; 36 weeks p = 0.021). The risk estimate for the Patient Neurotoxicity Questionnaire (PNQ) was also statistically significant (OR = 5.78, 95 % CI = 1.63-20.5). The European Organisation of Research and Treatment of Cancer (EORTC) quality of life, total pain score and pain interference showed no significance (p = 0.46, p = 0.9, p = 0.37 respectively). A trend was observed indicating that vitamin B12 may reduce the onset and severity of CIPN.


An oral B group vitamin as an adjunct to neurotoxic chemotherapy regimens was not superior to placebo (p > 0.05) for the prevention of CIPN. Patients taking the B group vitamin perceived a reduction in sensory peripheral neuropathy in the PNQ. Moreover, a robust clinical study is warranted given that vitamin B12 may show potential in reducing the onset and severity of CIPN. Trial number: ACTRN12611000078954 Protocol number: UH2010000749.


B vitamins; CIPN; Chemotherapy-induced peripheral neuropathy; Taxanes; Vincristine; Vitamin B12

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