A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Condition: Cancer
Intervention: Multivitamin (MV); Multivitamin + Vitamin B12 + Vitamin B6; Chemotherapy
Intervention description: 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.; Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections; Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)
Ranges of cumulative doses (in mg/m2) are:
paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800
Intervention MeSH terms: Vitamins; Vitamin B 12; Vitamin B 6; Pyridoxal; Pyridoxine; Vitamin B Complex; Vincristine; Vinorelbine; Docetaxel; Cisplatin; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin B-12; Vitamin B-6; Chemotherapy-Induced Neuropathy; Taxanes; Vinca alkaloid; Heavy metals; Neuropathy; Nerve pain

Summary:

      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.
    

Eligibility criteria:

        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.