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

NCT00659269 | Completed Phase 3 Results DMC

• 2 other identifiers: INST 0553CNCI-2012-00946
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 5

Brief Summary

Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Neurotoxicity Assessment at Baseline

  Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.

  At study start; prior to treatment (week 0)

• Neurotoxicity Assessment at Cycle 2

  Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.

  2 weeks

• Neurotoxicity Assessment at Cycle 4

  Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.

  4 weeks

• Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

  Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.

  4 weeks

Study Arms (2)

Multivitamin (MV)

ACTIVE COMPARATOR

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Dietary Supplement: Multivitamin (MV); Drug: Chemotherapy

Multivitamin + Vitamin B12 + Vitamin B6

EXPERIMENTAL

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts). The patient will also take the following, starting on the first day of chemotherapy: 1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts) 2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6; Drug: Chemotherapy

Interventions

Multivitamin (MV) DIETARY_SUPPLEMENT

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.

Multivitamin (MV)

Multivitamin + Vitamin B12 + Vitamin B6 DIETARY_SUPPLEMENT

Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6

Chemotherapy DRUG

Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine) Ranges of cumulative doses (in mg/m2) are: paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800

Also known as: Cisplatin (Platinol, Platinol-AQ), Oxaliplatin (Eloxatin), Paclitaxel (Taxol, Abraxane), Docetaxel (Taxotere), Vincristine (Oncovin), Vinorelbine tartrate (Navelbine)

Multivitamin (MV); Multivitamin + Vitamin B12 + Vitamin B6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (5)

University of New Mexico Cancer Center @ Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States

Location

Cancer Center at Presbyterian Hospital

Albuquerque, New Mexico, 87110, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

Related Links

• New Mexico Cancer Care Alliance
• University of New Mexico Cancer Center

MeSH Terms

Conditions

Neoplasms; Neuralgia

Interventions

Geritol; Vitamin B 12; Vitamin B 6; Drug Therapy; Cisplatin; Oxaliplatin; Paclitaxel; Albumin-Bound Paclitaxel; Docetaxel; Vincristine; Vinorelbine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Picolines; Pyridines; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Indolizidines; Indolizines

Limitations and Caveats

The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with.

Results Point of Contact

• Title: Zoneddy Dayao, MD
• Organization: University of New Mexico

zdayao@salud.unm.edu

5059250404

Study Officials

• Zoneddy Dayao, MD

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: July 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: February 26, 2016
• Results First Posted: January 25, 2016

Record last verified: 2016-01

Locations

US (5)