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

May 26, 2023 updated by: Han Xi Zhao, Shandong Cancer Hospital and Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • epigallocchin-3-gallate

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Study Chair: Ligang Xing, MD, PhD, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTEBC-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms Malignant

Clinical Trials on EGCG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe