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Sorafenib-induced Hand- Foot Skin Reaction Treatment

This study has been terminated.
(Study was halted due to poor subject accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667589
First Posted: April 28, 2008
Last Update Posted: June 5, 2013
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.
Collaborator:
Bayer
Information provided by (Responsible Party):
Dennis West, Northwestern University
  Purpose
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

Condition Intervention 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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Dennis West, Northwestern University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 6
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
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
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

Responsible Party: Dennis West, Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00667589     History of Changes
Other Study ID Numbers: STU2149
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: February 26, 2013
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