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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- effective rate of pruritus relieving
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Aprepitant and placebo
aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;
干预措施: Aprepitant (Drug)
Aprepitant and placebo
aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;
干预措施: Placebo of desloratadine (Drug)
desloratadine and placebo
placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28
干预措施: Desloratadine (Drug)
desloratadine and placebo
placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28
干预措施: Placebo of aprepitant (Drug)
结局指标
主要结局
effective rate of pruritus relieving
时间窗: 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
次要结局
- Change from baseline quality of life assessment at treatment ends(baseline, 28 days at the treatment ends)
- duration of pruritus relieving(12 weeks at the follow-up end)
研究者
Li Zhang, MD
M.D. Professor
Sun Yat-sen University