Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Phase 2

Completed

• Conditions: ITCH
• Interventions: Drug: Aprepitant; Drug: Prednisone; Drug: Fexofenadine

• Registration Number: NCT01683552
• Lead Sponsor: Campus Bio-Medico University

Brief 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.

Detailed Description

Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-11
• Last Update Submitted: 2012-09-11
• Study First Posted: 2012-09-12
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant after anti-itch standard therapy	Fexofenadine	Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
Aprepitant	Aprepitant	Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
Aprepitant after anti-itch standard therapy	Prednisone	Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
Aprepitant after anti-itch standard therapy	Aprepitant	Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

Primary Outcome Measures

Name	Time	Method
Severity of ITCH	once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy	Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period.; Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as \> 50% reduction of pruritus intensity compared to the baseline value.

Trial Locations

Locations (1)

Campus Bio-Medico of Rome University; 🇮🇹 Roma, Italy