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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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.
Zoneddy Dayao, MD
UNM Cancer Center
United States: Institutional Review Board
|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|