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May 24, 2026Asian Pacific Journal of Cancer PreventionOpen Access

Oral Vitamin B12 versus Placebo for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Gynecological Cancer Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

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Why the study?

The efficacy of vitamin B12 in preventing chemotherapy-induced peripheral neuropathy in patients with gynecological cancer receiving neurotoxic chemotherapy needed evaluation.

Does oral vitamin B12 prevent chemotherapy-induced peripheral neuropathy in gynecological cancer patients receiving neurotoxic chemotherapy?

Comparison

Oral vitamin B12 (500 micrograms) vs placebo

Design

Randomized, double-blind, placebo-controlled trial

Follow-up

Four weeks after completing six cycles

Key result

Oral vitamin B12 significantly reduced the incidence of chemotherapy-induced peripheral neuropathy compared to placebo (5% vs 20%, OR 0.21) in gynecological cancer patients.

Authors

PIPutsarat InsinTCTrinya ChaiwongsaNPNisa Prueksaritanond

Discussion

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Overview

May support oral vitamin B12 prophylaxis for CIPN in gynecological cancer patients on platinum chemo; extends RCT evidence for prevention.

Key Points

  • This trial aims to assess vitamin B12's efficacy in preventing chemotherapy-induced peripheral neuropathy in gynecological cancer patients.
  • Randomized, double-blind, placebo-controlled trial
  • Forty gynecological cancer patients receiving chemotherapy were enrolled
  • Participants received either vitamin B12 (500 mcg) or placebo twice daily during chemotherapy.
  • CIPN incidence was 5% in the vitamin B12 group vs. 20% in the placebo group (p = 0.008; OR 0.21, 95% CI: 0.07-0.66)
  • No significant differences in quality of life scores or adverse effects (p > 0.05)
  • Vitamin B12 demonstrated a favorable safety profile in this population.

Study Design

Type

RCT (n=40)

Blinding

Double-blind

Randomization

1:1 block randomization

Multicenter

No

Structured PICO

Does oral vitamin B12 prevent chemotherapy-induced peripheral neuropathy in gynecological cancer patients receiving neurotoxic chemotherapy?

P
Population
40 gynecological cancer patients undergoing neurotoxic chemotherapy (taxane-based combinations with carboplatin [87.5%] or cisplatin [12.5%])
I
Intervention
Vitamin B12 (cyanocobalamin) 500 micrograms, administered as two oral tablets twice daily from the start of chemotherapy until four weeks after completing six cycles
C
Comparator
Placebo, administered as two oral tablets twice daily from the start of chemotherapy until four weeks after completing six cycles
O
Outcome
Incidence of chemotherapy-induced peripheral neuropathy (CIPN), measured by the Patient Neurotoxicity Questionnaire (PNQ) score, and quality of life, assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)patient reported

Main Result

Effect estimate: OR 0.21 (95% CI 0.07-0.66)

Absolute Event Rate: 5% vs 20%

p-value: p=0.008

Oral vitamin B12 significantly reduces the incidence of chemotherapy-induced peripheral neuropathy in gynecological cancer patients receiving neurotoxic chemotherapy.

Limitations

  • Small sample size limiting generalizability
  • Reliance on patient-reported outcomes (PNQ score and FACT/GOG-Ntx) which may introduce subjective bias
  • Short duration of treatment and follow-up period
  • Heterogeneous study population regarding chemotherapeutic regimens

Cite This Study

Insin et al. (2026) conducted an RCT in Gynecological cancer undergoing neurotoxic chemotherapy (n=40). Oral Vitamin B12 (cyanocobalamin) vs. Placebo was evaluated on Incidence of chemotherapy-induced peripheral neuropathy (PNQ score ≥ 4) (OR 0.21, 95% CI 0.07-0.66, p=0.008). Oral vitamin B12 significantly reduced the incidence of chemotherapy-induced peripheral neuropathy compared to placebo (5% vs 20%, OR 0.21) in gynecological cancer patients.

synapsesocial.com/papers/6a12959d48a0ea1665671b0ahttps://doi.org/10.31557/apjcp.2026.27.5.1747
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A randomized clinical trial assessing the efficacy of vitamin B prophylaxis in attenuating paclitaxel-induced neuropathy and the imperative use of gabapentin in diabetic ovarian cancer patients2026
  2. 2Vitamin E for prophylaxis against chemotherapy-induced neuropathy2005 · 210 citations
  3. 3Vitamin D status and chemotherapy-induced peripheral neuropathy: A scoping review2025
  4. 4A Novel Approach of Intraneural Facilitation Versus Standard Physical Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial2026
  5. 5Effect of intravenous vitamin C administration on chemotherapy-induced adverse events in patients with nasopharyngeal cancer2026