Sorafenib-induced Hand- Foot Skin Reaction Treatment
This study has been terminated.
(Study was halted due to poor subject accrual.)
Sponsor:
Northwestern University
Collaborator:
Bayer
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT00667589
First received: April 24, 2008
Last updated: May 28, 2013
Last verified: May 2013
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 Northwestern University:
Primary Outcome Measures:
- Change in Skindex-16 Total Score Between Baseline and 8 Weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667589
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Dennis West, Professor in Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00667589 History of Changes |
| Other Study ID Numbers: | STU2149 |
| Study First Received: | April 24, 2008 |
| Results First Received: | February 26, 2013 |
| Last Updated: | May 28, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
sorafenib rash hand foot skin reaction |
Additional relevant MeSH terms:
|
Emollients Fluocinonide Tazarotene Anti-Allergic Agents Anti-Inflammatory Agents Dermatologic Agents Glucocorticoids |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Keratolytic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015