Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Last updated: April 21, 2022
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05348278
SI790/2021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients who has plan to receive capecitabine at the dosage of at least 2000 mg/m2 D1-14every 21 days for at least 3 cycles

Exclusion

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

Study Design

Total Participants: 214
Study Start date:
December 20, 2021
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Division of medical oncology, department of medicine Siriraj Hospital

    Bangkok, 10700
    Thailand

    Active - Recruiting

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