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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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Abstract

Introduction

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.

Methods

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.

Results

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.

Conclusion

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

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Acknowledgments

We would like to thank Bio Concepts Pty Ltd. for supplying the supplemental product and assisting the research position to conduct this trial. Acknowledgement also goes to all the oncology and neurological staff at the Princess Alexandra Hospital and the members of the former Centre for Integrative and Clinical Medicine at the University of Queensland for their assistance during the study. A special acknowledgement goes to Dr. Samantha Coulson for her detailed editing of the manuscript and assistance with this manuscript.

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Authors and Affiliations

  1. The University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia

    Janet M. Schloss & Paul Masci

  2. Endeavour College of Natural Health, Brisbane, 4006, Australia

    Janet M. Schloss

  3. Medical Oncology Group of Australia, Clinical Oncology Society of Australia, Queensland Clinical Oncology Group, Brisbane, 4000, Australia

    Maree Colosimo

  4. Neurology Fellow at Queensland Health, Department of Neurology, Ned Hanlon Building, RBWH, Herston, Brisbane, 4006, Australia

    Caroline Airey

  5. The University of Sydney, Sydney Medical School, Sydney, 2006, Australia

    Anthony W. Linnane & Luis Vitetta

  6. Medlab Clinical Ltd, Sydney, 2015, Australia

    Anthony W. Linnane & Luis Vitetta

Authors
  1. Janet M. Schloss
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  2. Maree Colosimo
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  3. Caroline Airey
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  4. Paul Masci
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  5. Anthony W. Linnane
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  6. Luis Vitetta
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Corresponding author

Correspondence to Janet M. Schloss.

Ethics declarations

Ethics statement

The study design complied with the Helsinki Declaration and was approved by the University of Queensland’s Human Research Ethics Committee (UH 2010000749) and by the Princess Alexandra Hospital’s Human Research Ethics Committee (HREC/10/QPAH/140).

Funding

The authors have received no financial support for the research, authorship and/or publication of this article.

Conflicts of interest

Luis Vitetta has received National Institute of Complementary Medicine and National Health and Medical Research Council of Australia competitive funding and industry support for research into nutraceuticals and herbal medicines. The authors declare no other potential conflicts of interest with respect to research, authorship and/or publication of this article.

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Schloss, J.M., Colosimo, M., Airey, C. et al. A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN). Support Care Cancer 25, 195–204 (2017). https://doi.org/10.1007/s00520-016-3404-y

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  • DOI: https://doi.org/10.1007/s00520-016-3404-y

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