Sorafenib-induced Hand- Foot Skin Reaction Treatment

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

Detailed Description
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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.

Official Title
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Four-arm Study to Evaluate Urea 40% Cream, Fluocinonide 0.05% Cream, Tazarotene 0.1% Cream, and an Emollient Cream for the Treatment of Hand-foot Skin Reaction Related to the Use of Multi-targeted Tyrosine Kinase Inhibitor Sorafenib.

Conditions
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Hand-foot Skin Reaction, Rash

Intervention / Treatment
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* Drug: urea 40% cream
* Drug: fluocinonide 0.05% cream
* Drug: tazarotene 0.1% cream
* Drug: bland emollient cream (Udderly smooth® Udder Cream)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: urea 40% cream<br> | Drug: urea 40% cream<br>* urea 40% cream applied twice per day to affected areas<br>* Other names: carmol 40;|
| Experimental: fluocinonide 0.05% cream<br> | Drug: fluocinonide 0.05% cream<br>* fluocinonide 0.05% cream applied twice per day to affected areas<br>|
| Experimental: tazarotene 0.1% cream<br> | Drug: tazarotene 0.1% cream<br>* tazarotene 0.1% cream applied twice per day to affected areas<br>* Other names: tazarac;|
| Experimental: bland emollient cream<br> | Drug: bland emollient cream (Udderly smooth® Udder Cream)<br>* bland emollient cream applied twice per day to affected areas<br>* Other names: Udderly smooth® Udder Cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skindex-16 Total Score Between 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. | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Skindex-16 Total Score Between 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. | baseline and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sorafenib, rash, hand foot skin reaction