Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
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
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
Daniele Santini, MD, PhD
Campus Bio-Medico of Rome University
Italy: Ethics Committee