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

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 Dietary Supplement: Vitamin B12, Vitamin B6	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study 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 Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin Infuvite Adult Infuvite Pediatric

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:	450
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2015
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: MV alone Multivitamin only	Dietary Supplement: Multivitamin Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.
Experimental: MV+B6+B12 Multivitamin, plus B6 tablets and B12 injections	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: MV alone

Multivitamin only

Dietary Supplement: Multivitamin

Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

Experimental: MV+B6+B12

Multivitamin, plus B6 tablets and B12 injections

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, New Mexico
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505

Sponsors and Collaborators

New Mexico Cancer Care Alliance

Investigators


Principal Investigator:	Zoneddy Dayao, MD	UNM Cancer Center

More Information

Additional Information:

New Mexico Cancer Care Alliance This link exits the ClinicalTrials.gov site

University of New Mexico Cancer Center This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:	NCT00659269 History of Changes
Other Study ID Numbers:	INST 0553C, NCI-2012-00946
Study First Received:	April 14, 2008
Last Updated:	March 3, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by New Mexico Cancer Care Alliance:


Vitamin B-12 Vitamin B-6 Chemotherapy-Induced Neuropathy Taxanes	Vinca alkaloid Heavy metals Neuropathy Nerve pain

Additional relevant MeSH terms:


Hydroxocobalamin Pyridoxal Pyridoxine Vitamin B 12 Vitamin B 6 Vitamin B Complex Vitamins	Growth Substances Hematinics Hematologic Agents Micronutrients Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015