Clinical trial · Interventional
Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
NCT01683552CI-TRIAL-00008008AprepItcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ITCH | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant | Drug | — | UNRESOLVED |
| Fexofenadine | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Aprepitant
- description
- Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
- interventionNames
- Drug: Aprepitant
- type
- OTHER
- label
- Aprepitant after anti-itch standard therapy
- 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
- interventionNames
- Drug: Aprepitant
- Drug: Prednisone
- Drug: Fexofenadine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSantini D, Vincenzi B, Guida FM, Imperatori M, Schiavon G, Venditti O, Frezza AM, Berti P, Tonini G. Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study. Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18. PMID 22995650