Aprepitant in the Management of Biological Therapies-related Severe Pruritus (AprepIt)

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 2

Conditions: ITCH

Treatments: Drug: Prednisone; Drug: Aprepitant; Drug: Fexofenadine

Study type: Interventional

Funder types: Other

Identifiers

NCT01683552

Aprepitant-Itch

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Aprepitant

Other group

Description:

Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus

Treatment:

Drug: Aprepitant

Aprepitant after anti-itch standard therapy

Other group

Description:

Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

Treatment:

Drug: Aprepitant

Drug: Fexofenadine

Drug: Prednisone