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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Improvement of neuropathy scores from baseline to the completion of 2 cycles will be analyzed.The same measurement after 4 cycles also will be analyzed & will be reported.

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Zoneddy Dayao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNM Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

INST 0553C

NCT ID:

NCT00659269

Start Date:

July 2006

Completion Date:

December 2014

Related Keywords:

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

Name

Location
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Hematology Oncology Associates Albuquerque, New Mexico  87106
University of New Mexico Cancer Center @ Lovelace Medical Center Albuquerque, New Mexico  87102
Cancer Center at Presbyterian Hospital Albuquerque, New Mexico  87110