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
  Purpose

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.


Condition Intervention Phase
ITCH
Drug: Aprepitant
Drug: Prednisone
Drug: Fexofenadine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients

Resource links provided by NLM:


Further study details as provided by Campus Bio-Medico University:

Primary Outcome Measures:
  • 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.



Enrollment: 45
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aprepitant
Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
Drug: Aprepitant
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
Other Name: Emend
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
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683552

Locations
Italy
Campus Bio-Medico of Rome University
Roma, Italy, 00128
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
Principal Investigator: Daniele Santini, MD, PhD Campus Bio-Medico of Rome University
  More Information

No publications provided by Campus Bio-Medico University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniele Santini, MD, PhD, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01683552     History of Changes
Other Study ID Numbers: Aprepitant-Itch
Study First Received: September 5, 2012
Last Updated: September 11, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Campus Bio-Medico University:
ITCH

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Prednisone
Fexofenadine
Aprepitant
Fosaprepitant
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014