Sorafenib-induced Hand- Foot Skin Reaction Treatment

Phase 2

Terminated

• Conditions: Hand-foot Skin Reaction; Rash
• Interventions: Drug: urea 40% cream; Drug: fluocinonide 0.05% cream; Drug: tazarotene 0.1% cream; Drug: bland emollient cream (Udderly smooth® Udder Cream)

• Registration Number: NCT00667589
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

Detailed Description

This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Study Timeline

• Study First Submitted: 2008-04-24
• Study First Submitted QC: 2008-04-25
• Study First Posted: 2008-04-28
• Study Start: 2008-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-02-26
• Results First Submitted QC: 2013-04-22
• Status Verified: 2013-05
• Results First Posted: 2013-05-27
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
• Subjects must be 18 years or older.
• Patients must provide written informed consent to participate in the study.
• Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
• Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria

• Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
• Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
• Patients with pre-existing dermatological condition affecting the hands or feet.
• Women who have a positive pregnancy test or are lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urea 40% cream	urea 40% cream	-
fluocinonide 0.05% cream	fluocinonide 0.05% cream	-
tazarotene 0.1% cream	tazarotene 0.1% cream	-
bland emollient cream	bland emollient cream (Udderly smooth® Udder Cream)	-

Primary Outcome Measures

Name	Time	Method
Change in Skindex-16 Total Score Between Baseline and 8 Weeks	baseline and 8 weeks	The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Change in Skindex-16 Total Score Between Baseline and 2 Weeks	baseline and 2 weeks	The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States