Aprepitant in the Management of Biological Therapies-related Severe Pruritus

ITCH Clinical Trial

— AprepIt  

Official title:

Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683552
• Other study ID #: Aprepitant-Itch
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2012
• Last updated: September 11, 2012
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ITCH

Intervention

Drug:
• Aprepitant
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
• Prednisone
In the refractory group (VAS score =7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),
• Fexofenadine
In the refractory group (VAS score =7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Locations

Country	Name	City	State
Italy	Campus Bio-Medico of Rome University	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of ITCH	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.	once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy	No