Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

NCT05348278 | Unknown Phase 2

• 1 other identifier: SI790/2021
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand-Foot Syndrome

Keywords

hand foot syndrome; capecitabine; urea cream

Outcome Measures

Primary Outcomes (1)

• any HFS

  incidence of any HFS

  from starting capecitabine until 4 week after capecitabine discontinuation

Secondary Outcomes (3)

• severe HFS

  from starting capecitabine until 4 week after capecitabine discontinuation

• time to develop severe HFS

  from starting capecitabine until 4 week after capecitabine discontinuation

• capecitabine interruption

  from starting capecitabine until 4 week after capecitabine discontinuation

Study Arms (2)

standard of care

NO INTERVENTION

standard of care including hand and foot care, avoid friction

urea cream

EXPERIMENTAL

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

Drug: Urea cream

Interventions

Urea cream DRUG

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

Also known as: Softcare cream

urea cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

• Wongkraisri C, Chusuwanrak K, Laocharoenkeat A, Chularojanamontri L, Nimmannit A, Ithimakin S. Randomized controlled trial on the efficacy of topical urea-based cream in preventing capecitabine-associated hand-foot syndrome. BMC Cancer. 2025 Feb 17;25(1):275. doi: 10.1186/s12885-025-13684-1.

  PMID: 39962445 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Suthinee Ithimakin, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthinee Ithimakin, MD

CONTACT

+6624194489; aesi105@yahoo.co.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: December 20, 2021
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)