Sorafenib-induced Hand- Foot Skin Reaction Treatment

Northwestern University

Status and phase: Terminated; Phase 2

Conditions: Rash; Hand-foot Skin Reaction

Treatments: Drug: bland emollient cream (Udderly smooth® Udder Cream); Drug: tazarotene 0.1% cream; Drug: urea 40% cream; Drug: fluocinonide 0.05% cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00667589

STU2149

Details and patient eligibility

About

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

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 4 patient groups

urea 40% cream

Experimental group

Treatment:

Drug: urea 40% cream

fluocinonide 0.05% cream

Experimental group

Treatment:

Drug: fluocinonide 0.05% cream

tazarotene 0.1% cream

Experimental group

Treatment:

Drug: tazarotene 0.1% cream

bland emollient cream

Experimental group

Treatment:

Drug: bland emollient cream (Udderly smooth® Udder Cream)