A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Information source: New Mexico Cancer Care Alliance
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: Multivitamin (Dietary Supplement); Vitamin B12, Vitamin B6 (Dietary Supplement)
Phase: Phase 3
Status: Recruiting
Sponsored by: New Mexico Cancer Care Alliance Official(s) and/or principal investigator(s):
Zoneddy Dayao, MD, Principal Investigator, Affiliation: UNM Cancer Center
Overall contact:
Valerie Parks, Phone: 505-925-0390, Email: vparks@salud.unm.edu
Summary
Primary Objective: To determine the efficacy of the combination of vitamin B6 and B12 in
preventing chemotherapy induced neuropathy
Clinical Details
Official title: A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Valerie Parks, Phone: 505-925-0390, Email: vparks@salud.unm.edu
University of New Mexico Cancer Center, Albuquerque, New Mexico 87131, United States; Recruiting
Valerie Parks, Phone: 505-925-0390, Email: vparks@salud.unm.edu
Zoneddy Dayao, MD, Principal Investigator
Hematology Oncology Associates, Albuquerque, New Mexico 87106, United States; Recruiting
Debbie Winklejohn, RN, Phone: 505-938-5858, Email: debbiew@hoanm.com
University of New Mexico Cancer Center @ Lovelace Medical Center, Albuquerque, New Mexico 87102, United States; Recruiting
Jaime Diggs, RN, Phone: 505-925-7488, Email: jdiggs@salud.unm.edu
Zoneddy Dayao, MD, Principal Investigator
Cancer Center at Presbyterian Hospital, Albuquerque, New Mexico 87110, United States; Recruiting
Wendy Burman, RN, Email: wburman@phs.org
Bernard Agbemadzo, MD, Principal Investigator
New Mexico Cancer Care Associates, Santa Fe, New Mexico 87505, United States; Recruiting
Doreen Padilla, Phone: 505-955-7935, Email: doreen.padilla@nmcancercare.com
Karen LoRusso, MD, Principal Investigator
Additional Information
Starting date: July 2006
Last updated: November 12, 2012
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