Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients

Neoplasms Malignant Clinical Trial

Official title:

Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients: Phase I-II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758571
• Other study ID #: GTEBC-2023
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: Shandong Cancer Hospital and Institute
• Contact: Ligang Xing, MD,PhD
• Phone: 86-531-67626996
• Email: zhx87520052[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Pneumonia
• Lung Diseases, Interstitial
• Neoplasms
• Neoplasms Malignant
• Pneumonia

Intervention

Drug:
• EGCG
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.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0	CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment.	through study completion, an average of 1 year
Primary	Changes of imaging examination (chest CT) after administration	The changes of lung before and after treatment were judged by CT chest with or without contrast.	up to 2 weeks