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Aprepitant in the Management of Biological Therapies-related Severe Pruritus (AprepIt)

Primary Purpose

ITCH

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Aprepitant
Prednisone
Fexofenadine
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ITCH focused on measuring ITCH

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Campus Bio-Medico of Rome University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Aprepitant

Aprepitant after anti-itch standard therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2012
Last Updated
September 11, 2012
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT01683552
Brief Title
Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Acronym
AprepIt
Official Title
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ITCH
Keywords
ITCH

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant
Arm Type
Other
Arm Description
Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
Arm Title
Aprepitant after anti-itch standard therapy
Arm Type
Other
Arm Description
Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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
Intervention Name(s)
Fexofenadine
Intervention Description
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 Outcome Measure Information:
Title
Severity of ITCH
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.
Time Frame
once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Santini, MD, PhD
Organizational Affiliation
Campus Bio-Medico of Rome University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio-Medico of Rome University
City
Roma
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22995650
Citation
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.
Results Reference
derived

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Aprepitant in the Management of Biological Therapies-related Severe Pruritus

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