A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

Primary Objective:To determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy

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.

• Dietary Supplement: Multivitamin
  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.
• Dietary Supplement: Vitamin B12, Vitamin B6

  On the first day of chemotherapy, start

  1. pyridoxine 50 mg tid orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
  2. Vitamin B12 one mg. i.m., q 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

• Active Comparator: MV alone
  Multivitamin only
  Intervention: Dietary Supplement: Multivitamin
• Experimental: MV+B6+B12
  Multivitamin, plus B6 tablets and B12 injections
  Intervention: Dietary Supplement: Vitamin B12, Vitamin B6

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.