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NCT Number: NCT01683552

Aprepitant in the Management of Biological Therapies-related Severe Pruritus

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.

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Key information

Conditions

Itch

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Campus Bio-Medico of Rome University

Roma, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant

Drug

125 mg on day 1; 80 mg on day 3; 80 mg on day 5

Other names: Emend

Prednisone

Drug

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),

fexofenadine

Drug

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Primary outcomes

  1. Severity of ITCH

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

    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.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: AprepIt

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2012
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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