Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hand-Foot Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard of care

standard of care including hand and foot care, avoid friction

Group Type NO_INTERVENTION

No interventions assigned to this group

urea cream

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

Group Type EXPERIMENTAL

Urea cream

Intervention Type DRUG

apply 10% urea cream at both hands and feet twice daily

Interventions

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Urea cream

apply 10% urea cream at both hands and feet twice daily

Intervention Type DRUG

Other Intervention Names

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Softcare cream

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No