Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment (EGFR-TKIs)

May 15, 2021 updated by: Li Zhang, MD, Sun Yat-sen University

Aprepitant vs. Desloratadine in Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Related Pruritus: A Prospective, Randomized Control, Double-blinded, Phase II Clinical Trial

Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. VAS investigation will be taken once a week to treatment end (4 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized control, double-blinded, phase II clinical trial. Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment (1 week) compared to baseline score. The VAS inquiry will be taken once a week for 4 weeks. Quality of life investigation will be performed at baseline, 1 week and 4 weeks after treatment using SKINDEX-16 questionnaire. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender,and VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. Aprepitant arm will be administrated aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28; desloratadine arm will be administrated placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28. Tolerance evaluation will be taken according to National Cancer Institute (NCI)-Common Terminology Criteria (CTC) For Adverse Events (AE) V4.03.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510060
        • Cancer Center of Sun-Yat Sen University (CCSYSU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced or metastatic non small cell lung cancer

  • Undertaken EGFR TKIs treatment (gefitinib, erlotinib, icotinib, afatinib, etc)

    • 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  • Moderate or severe pruritus (VAS score ≥ 4) first occur after EGFR TKIs treatment
  • Life expectancy ≥ 3 months
  • Orally drug administration with no difficulty
  • pregnancy test negative in 7 days for women of child-bearing age; willing to take contraception measures.
  • Signed informed consent form (ICF)

Exclusion Criteria:

  • Systemically treatment with Neurokinin-1 (NK-1) receptor inhibitors, antihistamines drugs, antibiotics, cortical hormone therapy, antiepileptic drugs, immunosuppressive agents or other drugs might affect treatment in 4 weeks; or locally used of these drug in 2 weeks.
  • Existing skin lesions not EGFR TKIs related, such as skin infection, chronic dermatitis, Systemic Lupus Erythematosus (SLE), lymphoma or other diseases.
  • Total bilirubin ≥ 1.5 Upper Limit Of Normal (ULN)
  • Serum creatinine ≥mg/dl
  • AST or ALT ≥ 2.5 ULN without liver metastasis; or ≥ 5 ULN with liver metastasis.
  • Residual toxicity event ≥ CTC-AE grade 2, except peripheral neurotoxicities.
  • Central nervous system (CNS) metastasis or spinal compression; except no symptoms and with no cortical hormonotherapy in 4 weeks.
  • Clinical evidence of interstitial lung disease
  • Any severe or uncontrolled systemic diseases judged by investigators.
  • Any contraindication of Neurokinin-1 receptor inhibitors and desloratadine.

Discontinuation Criteria

  • Invalid subject after randomization
  • Major protocol violations judged by investigators.
  • Poor compliance
  • Intolerable adverse events
  • Subject withdraw ICF
  • Any pregnancy events
  • No clinical benefits due to clinical adverse events, laboratory abnormalities or other medical conditions
  • Other reasons of treatment discontinuation judged by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant and placebo
aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;
Drug: Aprepitant
aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Other Names:
  • Treatment arm: Aprepitant administration
Drug: Placebo of desloratadine
Placebo of desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Other Names:
  • Comparative arm: Placebo of Desloratadine administration
Active Comparator: desloratadine and placebo
placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28
Drug: Desloratadine
Desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Other Names:
  • Treatment arm: Desloratadine administration
Drug: Placebo of aprepitant
Placebo of aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Other Names:
  • Comparative arm: Placebo of aprepitant administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective rate of pruritus relieving
Time Frame: day 28 at the treatment ends
effective treatment of pruritus relieving defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score
day 28 at the treatment ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of pruritus relieving
Time Frame: 12 weeks at the follow-up end
the time from pruritus effective relief to VAS score increase ≥ baseline level, the VAS inquiry will be taken once a week.
12 weeks at the follow-up end
Change from baseline quality of life assessment at treatment ends
Time Frame: baseline, 28 days at the treatment ends
using SKINDEX-16 questionnaire to assess patients quality of life
baseline, 28 days at the treatment ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

January 2, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAPE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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