Clinical trial NCT05348278: Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome
Official title: Randomized Controlled Trial to Evaluate Efficacy of Urea-based Cream for Prevention of Capecitabine-associated Hand Foot Skin Reactions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hand-Foot Syndrome
Keywords: hand foot syndrome
capecitabine
urea cream
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2022-04-27
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: any HFS
timeFrame: from starting capecitabine until 4 week after capecitabine discontinuation
Secondary outcomes:
measure: severe HFS
timeFrame: from starting capecitabine until 4 week after capecitabine discontinuation
measure: time to develop severe HFS
timeFrame: from starting capecitabine until 4 week after capecitabine discontinuation
measure: capecitabine interruption
timeFrame: from starting capecitabine until 4 week after capecitabine discontinuation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Suthinee Ithimakin, MD
role: PRINCIPAL_INVESTIGATOR
References: