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

Sponsor:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00659269

Purpose

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets

Drug Information available for: Pyridoxine hydrochloride Pyridoxine Vitamin B 12 Hydroxocobalamin Vitamin B 6

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	228
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (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.
Multivitamin+B6+B12: Experimental	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

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.

Multivitamin+B6+B12: Experimental

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Patients must have a life expectancy of at least 24 weeks.
Patients must have a Zubrod performance status of 0-2.
Patients must sign an informed consent.
Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.

Exclusion Criteria:

Patients with symptomatic brain metastases are excluded from this study.
Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Patients may receive no other concurrent complementary medicines during this study.
Patients with neuropathy induced diabetes are not eligible for this study
Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659269

Contacts

Contact: Valerie Parks

505-272-0898

vparks@salud.unm.edu

Locations

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

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Claire Verschraegen, MD

University of New Mexico - CRTC

More Information

No publications provided

Responsible Party:	Universtiy oif New Mexico - CRTC ( Claire Verschraegen, MD; Principal Investigator )
Study ID Numbers:	INST 0553C
Study First Received:	April 14, 2008
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00659269 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Neuropathy
Vitamin B-12
Vitamin B-6

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Growth Substances
Hydroxocobalamin
Physiological Effects of Drugs
Hematologic Agents
Vitamin B 12

Vitamin B 6
Pharmacologic Actions
Pyridoxal
Therapeutic Uses
Vitamins
Pyridoxine
Micronutrients

ClinicalTrials.gov processed this record on November 09, 2009