ITCH Clinical Trial
Official title:
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Withdrawn |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 |