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

Sponsor:	New Mexico Cancer Care Alliance
Information provided by (Responsible Party):	New Mexico Cancer Care Alliance
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
Cancer	Dietary Supplement: Multivitamin, Vitamin B12, Vitamin B6. Dietary Supplement: Vitamin B12, Vitamin B6	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention
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: B Vitamins Cancer

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

U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

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 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Multivitamin alone	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.
Experimental: Multivitamin+B6+B12	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

Active Comparator: Multivitamin alone

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.

Experimental: Multivitamin+B6+B12

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

505-925-0390

vparks@salud.unm.edu

Locations

United States, New Mexico
University of New Mexico Cancer Center	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Valerie Parks 505-925-0390 vparks@salud.unm.edu
Principal Investigator: Zoneddy Dayao, MD
Hematology Oncology Associates	Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Debbie Winklejohn, RN 505-938-5858 debbiew@hoanm.com
University of New Mexico Cancer Center @ Lovelace Medical Center	Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: John Pierce, RN 505-925-7488 jpierce@salud.unm.edu
Principal Investigator: Zoneddy Dayao, MD
New Mexico Cancer Care Associates	Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Doreen Padilla 505-955-7935 doreen.padilla@nmcancercare.com
Principal Investigator: Karen LoRusso, MD

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Investigators

Principal Investigator:

Claire Verschraegen, MD

University of New Mexico

More Information

No publications provided

Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00659269 History of Changes
Other Study ID Numbers:	INST 0553C
Study First Received:	April 14, 2008
Last Updated:	December 29, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:

Patients
Vitamin B-12
Vitamin B-6
Chemotherapy-Induced Neuropathy

Additional relevant MeSH terms:

Hydroxocobalamin
Vitamin B 12
Vitamin B 6
Pyridoxine
Pyridoxal
Vitamin B Complex
Vitamins

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012