Study Stopped
Study was halted due to poor subject accrual.
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.
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 27, 2013
CompletedJune 5, 2013
May 1, 2013
2.5 years
April 24, 2008
February 26, 2013
May 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in Skindex-16 Total Score Between Baseline and 2 Weeks
baseline and 2 weeks
Study Arms (4)
urea 40% cream
EXPERIMENTALfluocinonide 0.05% cream
EXPERIMENTALtazarotene 0.1% cream
EXPERIMENTALbland emollient cream
EXPERIMENTALInterventions
urea 40% cream applied twice per day to affected areas
fluocinonide 0.05% cream applied twice per day to affected areas
tazarotene 0.1% cream applied twice per day to affected areas
bland emollient cream applied twice per day to affected areas
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Bayercollaborator
Study Sites (1)
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hae Bae
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis West, PhD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Dermatology
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 5, 2013
Results First Posted
May 27, 2013
Record last verified: 2013-05