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

Completed · Phase 3

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00659269

Run by

New Mexico Cancer Research Alliance

People needed

319

Starts

2006-07-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must have a life expectancy of at least 24 weeks.
• Patients must have a Zubrod performance status of 0-2.
• Patients must sign an informed consent.
• Patients may have a grade 0 (chemotherapy naive) or 1 neuropathy (history of prior chemotherapy) prior to entry.

You may not qualify if…

• Patients with symptomatic brain metastases are excluded from this study.
• Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• Patients may receive no other concurrent complementary medicines during this study.
• Patients with neuropathy induced diabetes are not eligible for this study
• Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Where it is running

• University of New Mexico Cancer Center @ Lovelace Medical Center — Albuquerque, New Mexico, United States
• Hematology Oncology Associates — Albuquerque, New Mexico, United States
• Cancer Center at Presbyterian Hospital — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• New Mexico Cancer Care Associates — Santa Fe, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.