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

NCT ID: NCT00659269

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Multivitamin (MV)

Intervention Type: 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.

Chemotherapy

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Multivitamin + Vitamin B12 + Vitamin B6

Intervention Type: 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

Chemotherapy

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

Other Intervention Names

Cisplatin (Platinol, Platinol-AQ); Oxaliplatin (Eloxatin); Paclitaxel (Taxol, Abraxane); Docetaxel (Taxotere); Vincristine (Oncovin); Vinorelbine tartrate (Navelbine)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoneddy Dayao, MD

Role: PRINCIPAL_INVESTIGATOR

UNM Cancer Center

Locations

University of New Mexico Cancer Center @ Lovelace Medical Center

Albuquerque, New Mexico, United States

Hematology Oncology Associates

Albuquerque, New Mexico, United States

Cancer Center at Presbyterian Hospital

Albuquerque, New Mexico, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

Countries

United States

Related Links

http://www.nmcca.org

New Mexico Cancer Care Alliance

http://www.cancer.unm.edu

University of New Mexico Cancer Center

Other Identifiers

NCI-2012-00946

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0553C

Identifier Type: -

Identifier Source: org_study_id