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

New Mexico Cancer Care Alliance

Status and phase: Completed; Phase 3

Conditions: Cancer

Treatments: Drug: Chemotherapy; Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6; Dietary Supplement: Multivitamin (MV)

Study type: Interventional

Funder types: Other

Identifiers

NCT00659269

INST 0553C

NCI-2012-00946 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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319 participants in 2 patient groups

Multivitamin (MV)

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: Multivitamin (MV)

Drug: Chemotherapy

Multivitamin + Vitamin B12 + Vitamin B6

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Multivitamin + Vitamin B12 + Vitamin B6

Drug: Chemotherapy