Status:
COMPLETED
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 st...
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 neuropa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
319 Patients enrolled
Trial Details
Trial ID
NCT00659269
Start Date
July 1 2006
End Date
June 1 2015
Last Update
February 26 2016
Active Locations (5)
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1
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
2
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
3
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, United States, 87110
4
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131