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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniele Santini, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01683552
First received: September 5, 2012
Last updated: September 11, 2012
Last verified: September 2012

September 5, 2012
September 11, 2012
September 2010
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01683552 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
ITCH
  • Drug: Aprepitant
    125 mg on day 1; 80 mg on day 3; 80 mg on day 5
    Other Name: Emend
  • 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),
  • 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)
  • Aprepitant
    Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
    Intervention: Drug: Aprepitant
  • 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
    Interventions:
    • Drug: Aprepitant
    • Drug: Prednisone
    • Drug: Fexofenadine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01683552
Aprepitant-Itch
No
Daniele Santini, Campus Bio-Medico University
Campus Bio-Medico University
Not Provided
Principal Investigator: Daniele Santini, MD, PhD Campus Bio-Medico of Rome University
Campus Bio-Medico University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP