Sorafenib-induced Hand- Foot Skin Reaction Treatment

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hand-foot Skin Reaction; Rash	Drug: urea 40% cream; Drug: fluocinonide 0.05% cream; Drug: tazarotene 0.1% cream; Drug: bland emollient cream (Udderly smooth® Udder Cream)	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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.
Study Start Date :	June 2008
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: urea 40% cream	Drug: urea 40% cream; urea 40% cream applied twice per day to affected areas; Other Name: carmol 40
Experimental: fluocinonide 0.05% cream	Drug: fluocinonide 0.05% cream; fluocinonide 0.05% cream applied twice per day to affected areas
Experimental: tazarotene 0.1% cream	Drug: tazarotene 0.1% cream; tazarotene 0.1% cream applied twice per day to affected areas; Other Name: tazarac
Experimental: bland emollient cream	Drug: bland emollient cream (Udderly smooth® Udder Cream); bland emollient cream applied twice per day to affected areas; Other Name: Udderly smooth® Udder Cream

Outcome Measures

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Primary Outcome Measures :

1. Change in Skindex-16 Total Score Between Baseline and 8 Weeks [ Time Frame: 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 :

1. Change in Skindex-16 Total Score Between Baseline and 2 Weeks [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Bayer

Investigators

Principal Investigator:	Dennis West, PhD	Northwestern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dennis West, Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier:	NCT00667589 History of Changes
Other Study ID Numbers:	STU2149
First Posted:	April 28, 2008
Results First Posted:	May 27, 2013
Last Update Posted:	June 5, 2013
Last Verified:	May 2013

Keywords provided by Dennis West, Northwestern University:

sorafenib; rash; hand foot skin reaction

Additional relevant MeSH terms:

Sorafenib; Tazarotene; Nicotinic Acids; Emollients; Fluocinonide; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Keratolytic Agents	Vitamin B Complex; Vitamins; Micronutrients; Growth Substances; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents