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Sponsored by: |
University of New Mexico |
Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00659269 |
Primary Objective:To determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy
Condition | Intervention | Phase |
Chemotherapy-Induced Neuropathy in Cancer Patients |
Dietary Supplement: Multivitamin, Vitamin B12, Vitamin B6. Dietary Supplement: Vitamin B12, Vitamin B6 |
Phase III |
MedlinePlus related topics: | Cancer Dietary Supplements |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Factorial Assignment |
Official Title: | A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. |
Estimated Enrollment: | 228 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Multivitamin alone: Active Comparator |
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.
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Multivitamin+B6+B12: Experimental |
Dietary Supplement: Vitamin B12, Vitamin B6
On the first day of chemotherapy, start
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients, 18 years of age or older, with a cancer treated with any of the following drugs are eligible:
Each patient will be allocated to the following 3 groups:
Exclusion Criteria:
Contact: Valerie Parks | 505-272-0898 | vparks@salud.unm.edu |
United States, New Mexico | |||||
Universtiy of New Mexico - CRTC | Recruiting | ||||
Albuquerque, New Mexico, United States, 87131 | |||||
Contact: Valerie Parks 505-272-0898 vparks@salud.unm.edu | |||||
Principal Investigator: Claire Verschraegen, MD |
University of New Mexico |
Principal Investigator: | Claire Verschraegen, MD | University of New Mexico - CRTC |
Responsible Party: | Universtiy oif New Mexico - CRTC ( Claire Verschraegen, MD; Principal Investigator ) |
Study ID Numbers: | INST 0553C |
First Received: | April 14, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00659269 |
Health Authority: | United States: Institutional Review Board |
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