NCT05758571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

February 8, 2023

Last Update Submit

May 26, 2023

Conditions

Interstitial PneumoniaNeoplasms Malignant

Keywords

EGCG

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

EGCG（Epigallocatechin-3-gallate ）

EXPERIMENTAL

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

Interventions

EGCGDRUG

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.

Also known as: epigallocchin-3-gallate
EGCG（Epigallocatechin-3-gallate ）

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Related Publications (1)

  • Yin X, Zhu W, Tang X, Yang G, Zhao X, Zhao K, Jiang L, Li X, Zhao H, Wang X, Yan Y, Xing L, Yu J, Meng X, Zhao H. Phase I/II clinical trial of efficacy and safety of EGCG oxygen nebulization inhalation in the treatment of COVID-19 pneumonia patients with cancer. BMC Cancer. 2024 Apr 17;24(1):486. doi: 10.1186/s12885-024-12228-3.

    PMID: 38632501DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialNeoplasms

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Ligang Xing, MD, PhD

    Shandong Cancer Hospital and Institute

    STUDY CHAIR

Central Study Contacts

Ligang Xing, MD,PhD

CONTACT

86-531-67626996zhx87520052@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 7, 2023

Study Start

January 5, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

CN(1)