The effect of pyridoxine for prevention of hand-foot syndrome in colon cancer patients with adjuvant chemotherapy using capecitabine: a randomized study
Not Applicable
- Conditions
- colon cancer
- Registration Number
- JPRN-UMIN000007314
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Pregnant or lactating, or planning to become pregnant. (15) History of hypersensitivity or severe adverse reaction to fluoropyrimidines. (3) Serious concurrent disease [including interstitial pneumonia, pulmonary fibrosis, intestinal paralysis, ileus, poorly controlled diabetes, liver cirrhosis or hepatitis (type B or C), history of myocardial infarction or unstable angina within past 6 months]. (4) Active multiple primary cancer (disease-free less than 5 years). (5) Concurrent infectious disease. (6) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the incidence of at least grade 2 HFS when comparing the groups.
- Secondary Outcome Measures
Name Time Method periods of safety profile (rate and severity of adverse events), cumulative incidence of HFS.