Aprepitant in the Management of Biological Therapies-related Severe Pruritus

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Campus Bio-Medico University
• Treatments: Aprepitant; Fexofenadine; Fosaprepitant; Prednisone; Terfenadine

Criteria

Inclusion Criteria:

• histologically confirmed diagnosis of solid tumor

• treatment with anti-EGFR antibodies or TKIs

• first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS) score)

Exclusion Criteria:

• oral treatment with antimycotics during 4 weeks preceding enrolment

• topical treatment during the previous 2 weeks

• concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.