Status:
COMPLETED
Study of Pyridoxine for Hand-Foot Syndrome
Lead Sponsor:
Asan Medical Center
Conditions:
Hand-foot Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled trials. The invest...
Detailed Description
Although pyridoxine has been used empirically for the prevention of capecitabine associated HFS, its efficacy needs to be demonstrated in prospective controlled trials. We estimated that the HFS rate ...
Eligibility Criteria
Inclusion
- Gastrointestinal tract cancer patients treated with capecitabine-containing chemotherapy as a first-line treatment were randomly allocated to concurrent treatment with pyridoxine or placebo.
- All patients were 18 to 70 years old
- Had Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- An estimated life expectancy \> 3 months
- Adequate bone marrow function, including white blood cell (WBC) count of \>3500 cells/㎕ and platelet count of \>100000/㎕
- Adequate renal function (serum creatinine concentration \<1.5 mg/㎗)
- Adequate liver function with (serum bilirubin concentration \<1.5 mg/㎗, transaminase \<3 times the upper normal limit, and serum albumin \>2.5 mg/㎗).
Exclusion
- Previous treatment for HFS
- Hypersensitivity to pyridoxine
- A combination of other malignancies
- Serious illnesses or medical conditions
- Immune suppression or positive human immunodeficiency virus (HIV) serology
- Pregnant or lactating women.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
389 Patients enrolled
Trial Details
Trial ID
NCT00446147
Start Date
June 1 2004
End Date
December 1 2006
Last Update
February 25 2014
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