Multi-Center Phase II Study on Efficacy of High-Slip Skin Care Pad for Hand-Foot Skin Reaction Caused by Sorafenib in Patients with Renal Cell Carcinoma

UMIN ID: UMIN000002016

Registered date:29/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 2009/05/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

High-slip skin care pad (Remois® Pad) Change pads every 2-3 days. Maximum 4 weeks.
10% Urea cream Apply and rub in well after clean affected site,2-3 times a day. Maximum 4 weeks.

Outcome(s)

• Primary Outcome: Incidence of Grade 2 or 3 HFSR
• Secondary Outcome: Sorafenib treatment compliance (dose reduction/discontinuation), Pain assessment (VAS), Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients undergoing combination therapy with cytokine therapy, chemotherapy, or molecularly targeted therapy 2) Patients who have used other molecularly targeted drug therapy 3) Patients in whom the underlying disease is a generalized dermatological disease 4) Patients with Grade 2 or higher HFSR on the hands 5) Patients with Grade 3 or higher adverse events other than HFSR 6) Patients with previously confirmed sorafenib-induced HFSR 7) Patients determined to be unsuitable by investigators 8) Patients who may otherwise compromise patient safety in the conduct of the trial or who may compromise protocol compliance

Related Information

• Primary Sponsor: Japanese Society of Renal Cancer (JSRC)
• Source(s) of Monetary Support: CReS Kyushu