A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Lesion counts in total face at completion of the study period (week 4)
研究概览
简要总结
The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZAC® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.
详细描述
Not suitable: no more information is needed to be described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven NSCLC diagnosis
- •Life expectancy over four weeks
- •absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
- •With normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
- •Suitable for EGFR-TKIs treatment and expectant duration over four weeks
- •No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
- •With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTC] grade ≥ 3)
- •No other concomitant therapy referred to the face skin during the study
- •Signed and dated informed consent
排除标准
- •Performance status ≥ 3(ECOG)
- •Pregnant or breast-feeding patients
- •The lesion counts can't be evaluated due to concomitant diseases or other conditions
- •Not suitable for EGFR-TKIs treatment
结局指标
主要结局
Lesion counts in total face at completion of the study period (week 4)
时间窗: 12 months
次要结局
未报告次要终点
研究者
Li Zhang
professor
Sun Yat-sen University