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

PHASE3CompletedINTERVENTIONAL
Enrollment

319

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2015

Conditions
Cancer
Interventions
DIETARY_SUPPLEMENT

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.

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

DRUG

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"

Trial Locations (5)

87102

University of New Mexico Cancer Center @ Lovelace Medical Center, Albuquerque

87106

Hematology Oncology Associates, Albuquerque

87110

Cancer Center at Presbyterian Hospital, Albuquerque

87131

University of New Mexico Cancer Center, Albuquerque

87505

New Mexico Cancer Care Associates, Santa Fe

All Listed Sponsors
lead

New Mexico Cancer Research Alliance

OTHER

NCT00659269 - A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients | Biotech Hunter | Biotech Hunter