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

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ClinicalTrials.gov Identifier: NCT02646020
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Li Zhang, MD, Sun Yat-sen University

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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Aprepitant Drug: Desloratadine Drug: Placebo of aprepitant Drug: Placebo of desloratadine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 III Clinical Trial
Study Start Date : December 2015
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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 Name: 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 Name: 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 Name: 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 Name: Comparative arm: Placebo of aprepitant administration




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646020


Contacts
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Contact: YuXiang Ma, M.D. 86-020-87343894 mayx@sysucc.org.cn
Contact: Yupeng Yang, M.D. 86-020-87343822 yangyp@sysucc.org.cn

Locations
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China, Guangdong
Cancer Center of Sun-Yat Sen University (CCSYSU) Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Li Zhang, Master    86-20-8734-3458    zhangli6@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Li Zhang, professor Sun Yat-sen University

Publications of Results:

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Responsible Party: Li Zhang, MD, M.D. Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02646020     History of Changes
Other Study ID Numbers: TAPE001
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Li Zhang, MD, Sun Yat-sen University:
pruritus
Non-small Cell Lung Cancer
Receptor, Epidermal Growth Factor
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pruritus
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Skin Diseases
Skin Manifestations
Signs and Symptoms
Loratadine
Aprepitant
Fosaprepitant
Desloratadine
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Cholinergic Antagonists
Cholinergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists