Official Title: “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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Factorial Assignment

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Multivitamin, Vitamin B12, Vitamin B6.
  • Multivitamin containing no more than 10 mg of pyridoxine or 10 microgram 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 pyridoxine 50 mg tid orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Multivitamin alone
• Experimental: Multivitamin+B6+B12

Primary Measures

• 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
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of New Mexico

Overall Clinical Trial Officials and Contacts

Claire Verschraegen, MD Principal Investigator University of New Mexico - CRTC  

Overall Contact: Valerie Parks 505-272-0898 vparks@salud.unm.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659269

Study ID Number: INST 0553C

ClinicalTrials.gov Identifier: NCT00659269

Health Authority: United States: Institutional Review Board