Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hand-Foot Syndrome
• Intervention / Treatment: Drug: Urea cream

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.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Suthinee Ithimakin, MD; Phone Number: +6624194489; Email: aesi105@yahoo.co.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Division of medical oncology, department of medicine Siriraj Hospital
    • Contact: Suthinee Ithimakin, MD; Phone Number: 662-419-4489; Email: aesi105@yahoo.co.th
    • Principal Investigator: Suthinee Ithimakin, MD
    • Sub-Investigator: Akarin Nimmannit, MD
    • Sub-Investigator: Concord Wongkraisri, MD
    • Sub-Investigator: Kriengkri Chusuwanrak, MD
    • Sub-Investigator: Leena Chularojanamontri, MD
    • Sub-Investigator: Apirom Laocharoenkeat, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Siriraj Hospital
• Investigators: Principal Investigator: Suthinee Ithimakin, MD, Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: capecitabine; hand foot syndrome; urea cream
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• Other Study ID Numbers: SI790/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No