ITCH Clinical Trial
— AprepItOfficial title:
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
Verified date | September 2012 |
Source | Campus Bio-Medico University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Italy | Campus Bio-Medico of Rome University | Roma |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02075632 -
Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
|
Phase 2 | |
Completed |
NCT04515056 -
Characterization of New Human Models of Non-histaminergic Itch
|
N/A | |
Completed |
NCT04076865 -
Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch
|
N/A | |
Completed |
NCT04588532 -
Characterization of BAM8-22 as a New Surrogate Model of Non-histaminergic Itch
|
N/A | |
Enrolling by invitation |
NCT05195177 -
Testing Protocol to Efficiently Induce Itch
|
N/A | |
Withdrawn |
NCT03943407 -
Characterization of the Toll-like Receptor 7-agonist Imiquimod 3.75% as a New Surrogate Model of Itch
|
N/A | |
Completed |
NCT04858360 -
Inhibition of Non-histaminergic Pruritus Applied Using 3 Different Pruritogens
|
N/A | |
Completed |
NCT04635254 -
The Effect of Halophyte-based Cream on Pain and Itch
|
N/A | |
Not yet recruiting |
NCT06201715 -
Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
|
N/A | |
Completed |
NCT06036589 -
Characterization of Bovine Adrenal Medulla as a Model of Non-histaminergic Itch
|
N/A | |
Completed |
NCT04554888 -
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
|
N/A | |
Completed |
NCT04387851 -
Learning Mechanisms for Placebo and Nocebo Studies on Somatosensory Sensations: a Systematic Review and Meta-analysis.
|
||
Completed |
NCT03928223 -
The Color of Itch; Itch Modification by Color Viewing
|
||
Not yet recruiting |
NCT06245564 -
Effect of Ketamine, Amitriptyline and Their Combination on Histaminergic and Non-histaminergic Itch
|
N/A | |
Completed |
NCT03576053 -
A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing
|
N/A | |
Completed |
NCT04700007 -
Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine (Second Sub-Project)
|
N/A | |
Terminated |
NCT02828787 -
Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.
|
N/A | |
Not yet recruiting |
NCT04197440 -
Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
|
N/A | |
Completed |
NCT04115462 -
A Relation of Morphine-induced Itch and Pain Processing
|
N/A | |
Completed |
NCT05249387 -
Characterization of Bovine Adrenal Medulla as a New Surrogate Model of Non-histaminergic Itch
|
N/A |