Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Hand-Foot Syndrome

Intervention / Treatment
-----------------
* Drug: Urea cream


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard of care<br>standard of care including hand and foot care, avoid friction | |
| Experimental: urea cream<br>use 10% urea cream apply at both hands and feet twice a day from time of starting capecitabine | Drug: Urea cream<br>* apply 10% urea cream at both hands and feet twice daily<br>* Other names: Softcare cream;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any HFS | incidence of any HFS | from starting capecitabine until 4 week after capecitabine discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severe HFS | grade 3 or 4 HFS | from starting capecitabine until 4 week after capecitabine discontinuation | 
| 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 | 
| capecitabine interruption | proportion of patient with capecitabine interruption due to HFS | from starting capecitabine until 4 week after capecitabine discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hand foot syndrome, capecitabine, urea cream