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Aprepitant in the Management of Biological Therapies-related Severe Pruritus

NCT ID: NCT01683552

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ITCH

Keywords

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ITCH

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Aprepitant

Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus

Group Type OTHER

Aprepitant

Intervention Type DRUG

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

Aprepitant after anti-itch standard therapy

Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

Group Type OTHER

Aprepitant

Intervention Type DRUG

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

Prednisone

Intervention Type 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

Intervention Type 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)

Interventions

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Aprepitant

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

Intervention Type DRUG

Prednisone

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),

Intervention Type DRUG

Fexofenadine

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)

Intervention Type DRUG

Other Intervention Names

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Emend

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Daniele Santini

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniele Santini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico of Rome University

Locations

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Campus Bio-Medico of Rome University

Roma, , Italy

Site Status

Countries

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Italy

References

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Santini D, Vincenzi B, Guida FM, Imperatori M, Schiavon G, Venditti O, Frezza AM, Berti P, Tonini G. Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study. Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18.

Reference Type DERIVED
PMID: 22995650 (View on PubMed)

Other Identifiers

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Aprepitant-Itch

Identifier Type: -

Identifier Source: org_study_id