Interstitial Pneumonia, Neoplasms Malignant
Conditions
Keywords
EGCG
Brief summary
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.
Detailed description
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.
Interventions
DRUGEGCG
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.
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0 | through study completion, an average of 1 year | CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment. |
| Changes of imaging examination (chest CT) after administration | up to 2 weeks | The changes of lung before and after treatment were judged by CT chest with or without contrast. |
Countries
China
Contacts
Primary ContactLigang Xing, MD,PhD
Outcome results
None listed