UnknownPhase 2/3

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Thailand214 participantsStarted 2021-12-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: \- patients who has plan to receive capecitabine at the dosage of at least 2000 mg/m2 D1-14 every 21 days for at least 3 cycles Exclusion Criteria: * preexisting neuropathy which was severe than grade 2 * history of allergy to urea cream * patients with previous use of capecitabine 2000 mg/m2 * patients who has prior routinely used of urea cream

What they're measuring

any HFS

Timeframe: from starting capecitabine until 4 week after capecitabine discontinuation

Trial details

NCT IDNCT05348278

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05

Contact for this trial

Suthinee Ithimakin, MD

+6624194489 aesi105@yahoo.co.th

View on ClinicalTrials.gov More Hand-Foot Syndrome trials