Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Hand-Foot Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348278
• Other study ID #: SI790/2021
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 20, 2021
• Est. completion date: August 2023

Study information

• Verified date: April 2022
• Source: Mahidol University
• Contact: Suthinee Ithimakin, MD
• Phone: +6624194489
• Email: aesi105[@]yahoo.co.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand-Foot Syndrome
• Syndrome

Intervention

Drug:
• Urea cream
apply 10% urea cream at both hands and feet twice daily

Locations

Country	Name	City	State
Thailand	Division of medical oncology, department of medicine Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any HFS	incidence of any HFS	from starting capecitabine until 4 week after capecitabine discontinuation
Secondary	severe HFS	grade 3 or 4 HFS	from starting capecitabine until 4 week after capecitabine discontinuation
Secondary	time to develop severe HFS	time for starting capecitabine to time of >grade II HFS reported	from starting capecitabine until 4 week after capecitabine discontinuation
Secondary	capecitabine interruption	proportion of patient with capecitabine interruption due to HFS	from starting capecitabine until 4 week after capecitabine discontinuation