Sorafenib-induced Hand- Foot Skin Reaction Treatment

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.

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: urea 40% cream	Drug: urea 40% cream; urea 40% cream applied twice per day to affected areas; Other Names: 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 Names: tazarac
EXPERIMENTAL: bland emollient cream	Drug: bland emollient cream (Udderly smooth® Udder Cream); bland emollient cream applied twice per day to affected areas; Other Names: Udderly smooth® Udder Cream

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (ESTIMATE): April 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 5, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: sorafenib; rash; hand foot skin reaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Keratolytic Agents; Anti-Allergic Agents; Tazarotene; Fluocinonide; Emollients
• Other Study ID Numbers: STU2149