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A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
This study is currently recruiting participants.
Study NCT00659269   Information provided by University of New Mexico
First Received: April 14, 2008   Last Updated: November 5, 2009   History of Changes

April 14, 2008
November 5, 2009
July 2006
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00659269 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase III
Interventional
Prevention, Randomized, Open Label, Factorial Assignment
Chemotherapy-Induced Neuropathy in Cancer Patients
  • Dietary Supplement: Multivitamin, Vitamin B12, Vitamin B6.
  • Dietary Supplement: Vitamin B12, Vitamin B6
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
228
July 2011
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Valerie Parks 505-272-0898 vparks@salud.unm.edu
United States
 
NCT00659269
Claire Verschraegen, MD; Principal Investigator, Universtiy oif New Mexico - CRTC
INST 0553C
University of New Mexico
 
Principal Investigator: Claire Verschraegen, MD University of New Mexico - CRTC
University of New Mexico
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP