Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Mahidol University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hand-Foot Syndrome

Treatments: Drug: Urea cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05348278

SI790/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

standard of care

No Intervention group

Description:

standard of care including hand and foot care, avoid friction

urea cream

Experimental group

Description:

use 10% urea cream apply at both hands and feet twice a day from time of starting capecitabine

Treatment:

Drug: Urea cream