AprepIt: Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Aprepitant Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus |
Drug: Aprepitant
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
Other Names:
|
| Other: Aprepitant after anti-itch standard therapy 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
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
Other Names:
Drug: 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),
Drug: 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)
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Campus Bio-Medico of Rome University | Roma | Italy | 00128 |
Sponsors and Collaborators
- Campus Bio-Medico University
Investigators
- Principal Investigator: Daniele Santini, MD, PhD, Campus Bio-Medico of Rome University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Aprepitant-Itch