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Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Primary Purpose

Hand-Foot Syndrome

Status

Recruiting

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Urea cream

About this trial

This is an interventional prevention trial for Hand-Foot Syndrome focused on measuring hand foot syndrome, capecitabine, urea cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Division of medical oncology, department of medicine Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard of care

urea cream

Arm Description

standard of care including hand and foot care, avoid friction

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

Outcomes

Primary Outcome Measures

any HFS

incidence of any HFS

Secondary Outcome Measures

severe HFS

grade 3 or 4 HFS

time to develop severe HFS

time for starting capecitabine to time of >grade II HFS reported

capecitabine interruption

proportion of patient with capecitabine interruption due to HFS

Full Information

NCT ID

NCT05348278

First Posted

April 21, 2022

Last Updated

April 21, 2022

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05348278

Brief Title

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

Siriraj Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand-Foot Syndrome

Keywords

hand foot syndrome, capecitabine, urea cream

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard of care

Arm Type

No Intervention

Arm Description

standard of care including hand and foot care, avoid friction

Arm Title

urea cream

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Urea cream

Other Intervention Name(s)

Softcare cream

Intervention Description

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

Primary Outcome Measure Information:

Title

any HFS

Description

incidence of any HFS

Time Frame

from starting capecitabine until 4 week after capecitabine discontinuation

Secondary Outcome Measure Information:

Title

severe HFS

Description

grade 3 or 4 HFS

Time Frame

from starting capecitabine until 4 week after capecitabine discontinuation

Title

time to develop severe HFS

Description

time for starting capecitabine to time of >grade II HFS reported

Time Frame

from starting capecitabine until 4 week after capecitabine discontinuation

Title

capecitabine interruption

Description

proportion of patient with capecitabine interruption due to HFS

Time Frame

from starting capecitabine until 4 week after capecitabine discontinuation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suthinee Ithimakin, MD

Phone

+6624194489

aesi105@yahoo.co.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suthinee Ithimakin, MD

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of medical oncology, department of medicine Siriraj Hospital

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suthinee Ithimakin, MD

Phone

662-419-4489

aesi105@yahoo.co.th

First Name & Middle Initial & Last Name & Degree

Suthinee Ithimakin, MD

First Name & Middle Initial & Last Name & Degree

Concord Wongkraisri, MD

First Name & Middle Initial & Last Name & Degree

Kriengkri Chusuwanrak, MD

First Name & Middle Initial & Last Name & Degree

Leena Chularojanamontri, MD

First Name & Middle Initial & Last Name & Degree

Apirom Laocharoenkeat, MS

First Name & Middle Initial & Last Name & Degree

Akarin Nimmannit, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

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