Aprepitant in the Management of Biological Therapies-related Severe Pruritus (AprepIt)
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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 |
- 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
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Drug: Aprepitant
125 mg on day 1; 80 mg on day 3; 80 mg on day 5
Other Name: Emend
|
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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 |
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| Italy | |
| Campus Bio-Medico of Rome University | |
| Roma, Italy, 00128 | |
| 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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Anti-Inflammatory 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 |
ClinicalTrials.gov processed this record on May 16, 2013