Schloss Janet M, Colosimo Maree, Airey Caroline, Masci Paul, Linnane Anthony W, Vitetta Luis
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.
Support Care Cancer. 2017 Jan;25(1):195-204. doi: 10.1007/s00520-016-3404-y. Epub 2016 Sep 9.
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.
化疗引起的周围神经病变（CIPN）是神经毒性化疗药物导致的一种使人衰弱的副作用。本研究旨在评估口服B族维生素与安慰剂相比，在预防接受神经毒性化疗的癌症患者发生CIPN方面的疗效和安全性。
进行了一项先导性、随机、安慰剂对照试验。邀请新诊断为癌症且正在使用紫杉烷类、奥沙利铂或长春新碱的患者参与。共有71名参与者（女性68%，男性32%）被纳入研究，并随机分为B族维生素组（n = 38）或安慰剂组（n = 33）。47名参与者的数据符合分析要求（B族维生素组n = 27，安慰剂组n = 22）。主要结局指标是由一名独立神经科医生评估的总神经病变评分。次要结局指标包括血清维生素B水平、生活质量、疼痛量表和患者神经毒性问卷。结局指标在基线、12周、24周和36周进行评估。
总神经病变评分（TNS）表明，与安慰剂相比，B族维生素并未显著降低CIPN的发生率（p = 0.73）。在患者感知的感觉性周围神经病变方面达到了统计学显著性（12周p = 0.03；24周p = 0.005；36周p = 0.021）。患者神经毒性问卷（PNQ）的风险估计也具有统计学显著性（OR = 5.78，95% CI = 1.63 - 20.5）。欧洲癌症研究与治疗组织（EORTC）的生活质量、总疼痛评分和疼痛干扰均无显著性（分别为p = 0.46、p = 0.9、p = 0.37）。观察到一种趋势，表明维生素B12可能会降低CIPN的发生和严重程度。
口服B族维生素作为神经毒性化疗方案的辅助用药，在预防CIPN方面并不优于安慰剂（p > 0.05）。服用B族维生素的患者在PNQ中感觉感觉性周围神经病变有所减轻。此外，鉴于维生素B12可能在降低CIPN的发生和严重程度方面显示出潜力，有必要进行一项有力的临床研究。试验编号：ACTRN12611000078954 方案编号：UH2010000749。
