Status:
TERMINATED
Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
Lead Sponsor:
Cook County Health
Conditions:
Hand and Foot Syndrome
Eligibility:
All Genders
Phase:
NA
Brief Summary
Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/...
Detailed Description
Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitab...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Any adult patient starting capecitabine-containing chemotherapy
- Has never had capecitabine before
- Performance status 0-2 using the ECOG classification
- Life expectancy more than 6 months
- Agreed to stop any vitamin supplements, apart from vitamin D.
- Liver function studies including AST/ALT within 3x upper limit of normal
- Signed informed consent must be obtained from participating individuals
Exclusion
Key Trial Info
Start Date :
March 21 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00767689
Start Date
March 21 2006
End Date
March 17 2010
Last Update
June 15 2023
Active Locations (1)
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1
John H stroger Jr hospital of cook county
Chicago, Illinois, United States, 60612