NCT05348278

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Randomized Controlled Trial to Evaluate Efficacy of Urea-based Cream for Prevention of Capecitabine-associated Hand Foot Skin Reactions

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hand-Foot Syndrome

Interventions

Type	Name	Description
DRUG	Urea cream	apply 10% urea cream at both hands and feet twice daily

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-05-01
• Completion: 2023-08-01
• First posted: 2022-04-27
• Last updated: 2022-04-27

Locations

1 site across 1 country: Thailand