Clinical trial · Interventional
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.
NCT00659269CI-TRIAL-00021145completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Multivitamin (MV) | Dietary Supplement | — | UNRESOLVED |
| Multivitamin + Vitamin B12 + Vitamin B6 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Multivitamin (MV)
- description
- 1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
- interventionNames
- Dietary Supplement: Multivitamin (MV)
- Drug: Chemotherapy
- type
- EXPERIMENTAL
- label
- Multivitamin + Vitamin B12 + Vitamin B6
- description
- 1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts). The patient will also take the following, starting on the first day of chemotherapy: 1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) 2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.
- interventionNames
- Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
* Taxanes, vinca alkaloid analogs, heavy metals.
* Each patient will be allocated to the following 3 groups:
* Group 1 (Heavy metals): Patients treated with cisplatin (\>25 mg/m2/week dose intensity) or oxaliplatin
* Group 2 (Taxane): Patients treated with paclitaxel, docetaxel or abraxane
* Group 3 (Vinca alkaloids): Patients treated with vincristine and vinorelbine.
2. Patients must have a life expectancy of at least 24 weeks.
3. Patients must have a Zubrod performance status of 0-2.
4. Patients must sign an informed consent.
5. Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.
Exclusion Criteria:
1. Patients with symptomatic brain metastases are excluded from this study.
2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
3. Patients may receive no other concurrent complementary medicines during this study.
4. Patients with neuropathy induced diabetes are not eligible for this study
5. Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.References
Publications (0)
Data not yet available
No reference posted for this study.