Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ITCH

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Prednisone
* Drug: Fexofenadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aprepitant<br>Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus | Drug: Aprepitant<br>* 125 mg on day 1; 80 mg on day 3; 80 mg on day 5<br>* Other names: Emend;|
| Other: Aprepitant after anti-itch standard therapy<br>Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week | Drug: Aprepitant<br>* 125 mg on day 1; 80 mg on day 3; 80 mg on day 5<br>* Other names: Emend;Drug: Prednisone<br>* 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),<br>Drug: Fexofenadine<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITCH