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Sorafenib-induced Hand- Foot Skin Reaction Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00667589
Recruitment Status : Terminated (Study was halted due to poor subject accrual.)
First Posted : April 28, 2008
Results First Posted : May 27, 2013
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Dennis West, Northwestern University

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667589


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Bayer
Investigators
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Principal Investigator: Dennis West, PhD Northwestern University
More Information
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Responsible Party: Dennis West, Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00667589    
Other Study ID Numbers: STU2149
First Posted: April 28, 2008    Key Record Dates
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:
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Fluocinonide
Tazarotene
Emollients
Dermatologic Agents
Keratolytic Agents
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents