Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients: Phase I-II Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Changes of imaging examination (chest CT) after administration
研究概览
简要总结
Epigallocatechin-3-gallate (EGCG) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. In addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (EGCG), including SARS-CoV-2.
In previous studies, we found that EGCG can prevent and cure radiation-induced normal tissue damage in tumor patients. In clinical studies, we found that EGCG can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. Thus, we designed this phase I-II clinical study in order to investigate the possible role of EGCG in the treatment interstitial pneumonia in tumor patients.
详细描述
In this phase I study, subjects were divided into four dose groups according to the improved Fibonacci method and were given different doses of EGCG to evaluate adverse events. At the same time, the researchers conducted a phase II study of EGCG in tumor patients with interstitial pneumonia. The Phase II study was conducted with a randomized, controlled, placebo dose determined by Phase I. the subjects were divided into two groups (experimental group and placebo group). To observe the effectiveness of EGCG, the researchers will use both clinician assessment and patient self-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed malignant tumors by pathology or cytology
- •COVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23
- •Moderate pneumonia, according to the diagnosis and treatment standard of COVID-19 in Peking Union Medical College Hospital
- •Pulmonary function of the patient can be treated with aerosol inhalation for 5-7 days
排除标准
- •Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of time
- •Caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia
- •Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
- •Need systemic use of immune suppressive agents
研究组 & 干预措施
EGCG（Epigallocatechin-3-gallate ）
Epigallocatechin-3-gallate (EGCG) (high pressure liquid chromatographic purity ≥ 95%; from Ningbo Hepu Biotechnology Co., Ltd.) is dissolved in 0.9% normal saline; 10ml is inhaled by atomization three times a day. From the beginning of the diagnosis and 7 days after the signing of the informed consent form, the medication can be continued according to the wishes of the patients, but the total medication time is not more than 14 days.
干预措施: EGCG (Drug)
结局指标
主要结局
Changes of imaging examination (chest CT) after administration
时间窗: up to 2 weeks
The changes of lung before and after treatment were judged by CT chest with or without contrast.
Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: through study completion, an average of 1 year
CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment.
次要结局
未报告次要终点
研究者
Han Xi Zhao
Principal investigator
Shandong Cancer Hospital and Institute