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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01683552
Other study ID # Aprepitant-Itch
Secondary ID
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


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
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