Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: Siriraj Hospital

Criteria

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