A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients - NCT00659269-87131 (Clinical Trial 215546)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy215546.aspx
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| City: |
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Albuquerque |
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State:
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NM |
| Zip Code: |
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87131 |
| Conditions: |
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Chemotherapy-Induced Neuropathy in Cancer Patients |
| Purpose: |
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Primary Objective:To determine the efficacy of the combination of vitamin B6 and B12 in
preventing chemotherapy induced neuropathy
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Universtiy of New Mexico Cancer Center
Albuquerque, NM 87131
United States
Primary Contact:
Valerie Parks
Email: vparks@salud.unm.edu
Phone: 505-272-0898
Secondary Contact:
Valerie Parks
Email: vparks@salud.unm.edu
Phone: 505-272-0898 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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