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Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

NCT05348278 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2022-04-27

No results posted yet for this study

Summary

Hand foot skin reaction (HFS) from capecitabine is one of the most common adverse events from capecitabine. Urea cream has been proved its benefit to prevent HFS from sorafenib. Prior study using urea cream prophylaxis in patients receiving capecitabine was negative. However, result from aformentioned study was reported primarily from result of first cycle capecitabine. Urea cream as a prevention of HFS from capecitabine has been used in clinical practice in Thailand according to expert's opinion. We conducted the study to evaluate wheter the urea cream can prevent HFS or severe HFS.

Conditions

  • Hand-Foot Syndrome

Interventions

DRUG

Urea cream

apply 10% urea cream at both hands and feet twice daily

Sponsors & Collaborators

  • Siriraj Hospital

    collaborator OTHER

  • Mahidol University

    lead OTHER

Principal Investigators

  • Suthinee Ithimakin, MD · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-05-31
Completion
2023-08-31

Countries

  • Thailand

Study Locations

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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 NCT05348278 on ClinicalTrials.gov