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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Aprepitant
Desloratadine
Placebo of aprepitant
Placebo of desloratadine
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring pruritus, Non-small Cell Lung Cancer, Receptor, Epidermal Growth Factor, tyrosine kinase inhibitor

Eligibility Criteria

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

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.

Sites / Locations

  • Cancer Center of Sun-Yat Sen University (CCSYSU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aprepitant and placebo

desloratadine and placebo

Arm Description

aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;

placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28

Outcomes

Primary Outcome Measures

effective rate of pruritus relieving
effective treatment of pruritus relieving defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score

Secondary Outcome Measures

duration of pruritus relieving
the time from pruritus effective relief to VAS score increase ≥ baseline level, the VAS inquiry will be taken once a week.
Change from baseline quality of life assessment at treatment ends
using SKINDEX-16 questionnaire to assess patients quality of life

Full Information

First Posted
December 10, 2015
Last Updated
May 15, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02646020
Brief Title
Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment
Acronym
EGFR-TKIs
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
pruritus, Non-small Cell Lung Cancer, Receptor, Epidermal Growth Factor, tyrosine kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant and placebo
Arm Type
Experimental
Arm Description
aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;
Arm Title
desloratadine and placebo
Arm Type
Active Comparator
Arm Description
placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Treatment arm: Aprepitant administration
Intervention Description
aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Intervention Type
Drug
Intervention Name(s)
Desloratadine
Other Intervention Name(s)
Treatment arm: Desloratadine administration
Intervention Description
Desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Intervention Type
Drug
Intervention Name(s)
Placebo of aprepitant
Other Intervention Name(s)
Comparative arm: Placebo of aprepitant administration
Intervention Description
Placebo of aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Intervention Type
Drug
Intervention Name(s)
Placebo of desloratadine
Other Intervention Name(s)
Comparative arm: Placebo of Desloratadine administration
Intervention Description
Placebo of desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
Primary Outcome Measure Information:
Title
effective rate of pruritus relieving
Description
effective treatment of pruritus relieving defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score
Time Frame
day 28 at the treatment ends
Secondary Outcome Measure Information:
Title
duration of pruritus relieving
Description
the time from pruritus effective relief to VAS score increase ≥ baseline level, the VAS inquiry will be taken once a week.
Time Frame
12 weeks at the follow-up end
Title
Change from baseline quality of life assessment at treatment ends
Description
using SKINDEX-16 questionnaire to assess patients quality of life
Time Frame
baseline, 28 days at the treatment ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center of Sun-Yat Sen University (CCSYSU)
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

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