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Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients


Phase 2
18 Years
85 Years
Not Enrolling
Both
ITCH

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Severity of ITCH

Outcome Description:

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.

Outcome Time Frame:

once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy

Safety Issue:

No

Principal Investigator

Daniele Santini, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Campus Bio-Medico of Rome University

Authority:

Italy: Ethics Committee

Study ID:

Aprepitant-Itch

NCT ID:

NCT01683552

Start Date:

September 2010

Completion Date:

November 2011

Related Keywords:

  • ITCH
  • ITCH
  • Pruritus

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