Clinical trial NCT05758571: Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients
Official title: Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients: Phase I-II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Interstitial Pneumonia
Neoplasms Malignant
Keywords: EGCG
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 year
measure: Changes of imaging examination (chest CT) after administration
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Ligang Xing, MD, PhD
role: STUDY_CHAIR
References: