Aprepitant in the Management of Immune Checkpoint Inhibitors Pruritus in Solid Cancer Patients

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

May 30, 2026

Study Completion Date

December 30, 2026

Conditions
Pruritus
Interventions
DRUG

EMEND® (EE mend) (aprepitant) capsules (80mg +125mg) Marketing Authorization Holder and Importer: Merck Sharp & Dohme (Israel-1996) Company Ltd.

"Total Treatment Duration: 1 cycle (1 administration of EMEND® capsules)~* Frequency: Patients will take EMEND® capsules at the start of new ICI.~* Dosing Schedule:~ * Day 1: EMEND® 125 mg, taken orally 1-2 hours before ICI administration.~ * Day 2: EMEND® 80 mg, taken orally in the morning.~ * Day 3: EMEND® 80 mg, taken orally in the morning. During the study period (12 weeks), participant must refrain from using any medications that could potentially interfere with the study's assessment of pruritus symptoms (e.g steroids, antihistamines)~Follow-up 1(7 days after the first capsule of Aprepitant): 12-PSS, safety assessment, QLQ-C30 Follow-up 2: 12-PSS, safety assessment Follow-up 3: 12-PSS, safety assessment Follow-up 4: 12-PSS, QLQ-C30, safety assessment Extended Follow-up: Recurrence of pruritus, long-term safety monitoring, QLQ-C30"

All Listed Sponsors
lead

Rabin Medical Center

OTHER