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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00446147 |
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Date of registration:
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09/03/2007 |
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Primary sponsor: |
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Public title:
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Study of Pyridoxine for Hand-Foot Syndrome
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Scientific title:
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Double-Blind Phase III Study of Pyridoxine vs Placebo for the Prevention of Capecitabine-induced Hand-Foot Syndrome |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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389 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00446147 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Contacts
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Name:
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Yoon-Koo Kang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asan Medical Center IRB |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hand-foot Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: Pyridoxine
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Primary Outcome(s)
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prevention of HFS
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Secondary Outcome(s)
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treatment of HFS
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Secondary ID(s)
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AMC-ONCGI-0403
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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