This trial is active, not recruiting.

Condition cancer
Treatments multivitamin (mv), multivitamin + vitamin b12 + vitamin b6
Phase phase 3
Sponsor New Mexico Cancer Care Alliance
Start date July 2006
End date June 2013
Trial size 450 participants
Trial identifier NCT00659269, INST 0553C, NCI-2012-00946


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Multivitamin only
multivitamin (mv)
Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm. 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)
Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections
multivitamin + vitamin b12 + vitamin b6
As in Arm 1, one 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: 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) Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses. Cumulative doses (in mg/m2) are: paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400

Primary Outcomes

Improvement of neuropathy scores from baseline to the completion of 2 cycles will be analyzed.The same measurement after 4 cycles also will be analyzed & will be reported.
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.
Principal investigator Zoneddy Dayao, MD
Description Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by New Mexico Cancer Care Alliance.