Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Phase 2

• Conditions: Hand-Foot Syndrome
• Interventions: Drug: Urea cream

• Registration Number: NCT05348278
• Lead Sponsor: Mahidol University

Brief 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.

Detailed Description

The patients who is planned to receive capecitabine for at least 3 cycles were enrolled in the study. The patients were randomized to receive 10% urea cream or standard measure. The patients were followed until the end of capecitabine treatment. The patients reported their symptoms of HFS and other adverse events (AE) before starting new cycle of capecitabine. Physician record of HFS and other AE, dose modification of capecitabine and compliance were extracted. We will report incidence of any HFS, \> grade 3 HFS, capecitabine interruption or delay or discontinuation and time to develop HFS among both arms. The results of the study will be used for optimal prophylactic measures in patients treated with capecitabine.

Study Timeline

• Study Start: 2021-12-20
• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-05
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urea cream	Urea cream	use 10% urea cream apply at both hands and feet twice a day from time of starting capecitabine

Primary Outcome Measures

Name	Time	Method
any HFS	from starting capecitabine until 4 week after capecitabine discontinuation	incidence of any HFS

Secondary Outcome Measures

Name	Time	Method
severe HFS	from starting capecitabine until 4 week after capecitabine discontinuation	grade 3 or 4 HFS
time to develop severe HFS	from starting capecitabine until 4 week after capecitabine discontinuation	time for starting capecitabine to time of \>grade II HFS reported
capecitabine interruption	from starting capecitabine until 4 week after capecitabine discontinuation	proportion of patient with capecitabine interruption due to HFS

Trial Locations

Locations (1)

Division of medical oncology, department of medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand