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Trial Title:
Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients
NCT ID:
NCT05758571
Condition:
Interstitial Pneumonia
Neoplasms Malignant
Conditions: Official terms:
Pneumonia
Neoplasms
Lung Diseases, Interstitial
Conditions: Keywords:
EGCG
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EGCG
Description:
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.
Arm group label:
EGCG（Epigallocatechin-3-gallate ）
Other name:
epigallocchin-3-gallate
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanxi Zhao, MD
Phone:
86-531-67626996
Email:
zhx87520052@163.com
Start date:
January 5, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758571
