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Study of Pyridoxine for Hand-Foot Syndrome

NCT00446147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2014-02-25

Study results available
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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 investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of HFS when given concurrently with capecitabine. The investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 HFS.

Conditions

  • Hand-foot Syndrome

Interventions

DRUG

Pyridoxine

100mg BID/daily, Per oral

DRUG

Placebo

placebo 100mg BID/daily, Per oral

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yoon-Koo Kang · Asan Medical Center IRB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00446147 on ClinicalTrials.gov