A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN).
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.
The University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. janet.schloss@uqconnect.edu.au.|Endeavour College of Natural Health, Brisbane, 4006, Australia. janet.schloss@uqconnect.edu.au.
Janet M
JM
Schloss
Medical Oncology Group of Australia, Clinical Oncology Society of Australia, Queensland Clinical Oncology Group, Brisbane, 4000, Australia.
Maree
M
Colosimo
Neurology Fellow at Queensland Health, Department of Neurology, Ned Hanlon Building, RBWH, Herston, Brisbane, 4006, Australia.
Caroline
C
Airey
The University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.
Paul
P
Masci
The University of Sydney, Sydney Medical School, Sydney, 2006, Australia.|Medlab Clinical Ltd, Sydney, 2015, Australia.
Anthony W
AW
Linnane
The University of Sydney, Sydney Medical School, Sydney, 2006, Australia.|Medlab Clinical Ltd, Sydney, 2015, Australia.
Luis
L
Vitetta
D000284:Administration, Oral; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D020258:Neurotoxicity Syndromes / Q000209:etiology / Q000517:prevention & control*; D009944:Organoplatinum Compounds / Q000009:adverse effects; D000077150:Oxaliplatin; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000517:prevention & control*; D011788:Quality of Life; D043823:Taxoids / Q000009:adverse effects; D014750:Vincristine / Q000009:adverse effects; D014803:Vitamin B Complex / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D043823:Taxoids; D014815:Vitamins; D000077150:Oxaliplatin; D014803:Vitamin B Complex; D014750:Vincristine
B vitamins; CIPN; Chemotherapy-induced peripheral neuropathy; Taxanes; Vincristine; Vitamin B12