Clinical trial NCT00659269: A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Official title: A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Vitamin B-12
Vitamin B-6
Chemotherapy-Induced Neuropathy
Taxanes
Vinca alkaloid
Heavy metals
Neuropathy
Nerve pain
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Neurotoxicity Assessment at Baseline
timeFrame: At study start; prior to treatment (week 0)
measure: Neurotoxicity Assessment at Cycle 2
timeFrame: 2 weeks
measure: Neurotoxicity Assessment at Cycle 4
timeFrame: 4 weeks
measure: Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center @ Lovelace Medical Center
state: New Mexico
city: Albuquerque
country: United States
facility: Hematology Oncology Associates
state: New Mexico
city: Albuquerque
country: United States
facility: Cancer Center at Presbyterian Hospital
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Zoneddy Dayao, MD
role: PRINCIPAL_INVESTIGATOR
References: