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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00659269
First received: April 14, 2008
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Cancer
Dietary Supplement: Multivitamin (MV)
Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6
Drug: Chemotherapy
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:


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

Primary Outcome Measures:
  • Neurotoxicity Assessment at Baseline [ Time Frame: At study start; prior to treatment (week 0) ] [ Designated as safety issue: Yes ]
    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.

  • Neurotoxicity Assessment at Cycle 2 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Neurotoxicity Assessment at Cycle 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Change in Neurotoxicity Assessment Between Cycle 4 and Baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 319
Study Start Date: July 2006
Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multivitamin (MV)
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)
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.
Drug: Chemotherapy

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

Other Names:
  • Cisplatin (Platinol, Platinol-AQ)
  • Oxaliplatin (Eloxatin)
  • Paclitaxel (Taxol, Abraxane)
  • Docetaxel (Taxotere)
  • Vincristine (Oncovin)
  • Vinorelbine tartrate (Navelbine)
Experimental: Multivitamin + Vitamin B12 + Vitamin B6

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

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

Other Names:
  • Cisplatin (Platinol, Platinol-AQ)
  • Oxaliplatin (Eloxatin)
  • Paclitaxel (Taxol, Abraxane)
  • Docetaxel (Taxotere)
  • Vincristine (Oncovin)
  • Vinorelbine tartrate (Navelbine)

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with symptomatic brain metastases are excluded from this study.
  2. Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  3. Patients may receive no other concurrent complementary medicines during this study.
  4. Patients with neuropathy induced diabetes are not eligible for this study
  5. 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
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
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:
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
Results First Received: June 18, 2015
Last Updated: January 27, 2016
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:
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Pyridoxal
Pyridoxine
Paclitaxel
Vincristine
Vinorelbine
Docetaxel
Vinca Alkaloids
Oxaliplatin
Cisplatin
Albumin-Bound Paclitaxel
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hematinics

ClinicalTrials.gov processed this record on September 23, 2016