Evidence map›Paper›PMID 27612466›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2017

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

Janet M Schloss, Maree Colosimo, Caroline Airey, Paul Masci, Anthony W Linnane, Luis Vitetta

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Review
  9. Patient-reported strategies for prevention and treatment of chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  10. Article
  11. Article
  12. Article
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  14. Article
  15. Targeting therapy-induced senescence as a novel strategy to combat chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Review
  16. Article
  17. Review
  18. Chemotherapy-induced polyneuropathy in cancer care-the patient perspective.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Janet M SchlossThe University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. janet.schloss@uqconnect.edu.au.
Maree ColosimoMedical Oncology Group of Australia, Clinical Oncology Society of Australia, Queensland Clinical Oncology Group, Brisbane, 4000, Australia.
Caroline AireyNeurology Fellow at Queensland Health, Department of Neurology, Ned Hanlon Building, RBWH, Herston, Brisbane, 4006, Australia.
Paul MasciThe University of Queensland, School of Medicine, Level 5, TRI, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.
Anthony W LinnaneThe University of Sydney, Sydney Medical School, Sydney, 2006, Australia.
Luis VitettaThe University of Sydney, Sydney Medical School, Sydney, 2006, Australia.
Princess Alexandra Hospital · AUThe University of Sydney · AUClinical Oncological Society of Australia · AUQueensland Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChemotherapy-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.

methodsA 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.

resultsThe 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.

conclusionAn 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.

Indexed as

Administration, OralAgedAntineoplastic AgentsFemaleHumansMaleMiddle AgedNeoplasmsNeurotoxicity SyndromesOrganoplatinum CompoundsOxaliplatinPeripheral Nervous System DiseasesQuality of LifeTaxoidsVincristineVitamin B ComplexAntineoplastic AgentsOrganoplatinum CompoundsOxaliplatinTaxoidsVincristineVitamin B ComplexVitaminsB vitaminsChemotherapy-induced peripheral neuropathyCIPNTaxanesVincristineVitamin B12

Identifiers

PMID27612466
OpenAlexW2513649088

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.