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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

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

NCT ID

NCT02646020

First Posted

December 10, 2015

Last Updated

May 15, 2021

Sponsor

Sun Yat-sen University

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

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

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Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

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