Back to resultsOxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients
Primary Purpose
Interstitial Pneumonia, Neoplasms Malignant
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
EGCG
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Pneumonia focused on measuring EGCG
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
Sites / Locations
- Shandong Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EGCG（Epigallocatechin-3-gallate ）
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05758571
First Posted
February 8, 2023
Last Updated
May 26, 2023
Sponsor
Shandong Cancer Hospital and Institute
1. Study Identification
Unique Protocol Identification Number
NCT05758571
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Pneumonia, Neoplasms Malignant
Keywords
EGCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGCG（Epigallocatechin-3-gallate ）
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EGCG
Other Intervention Name(s)
epigallocchin-3-gallate
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Participants With EGCG-Related Adverse Events as Assessed by CTCAE v4.0
Description
CTCAE v4.0 is an international standard for evaluating adverse event to cancer treatment.
Time Frame
through study completion, an average of 1 year
Title
Changes of imaging examination (chest CT) after administration
Description
The changes of lung before and after treatment were judged by CT chest with or without contrast.
Time Frame
up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ligang Xing, MD,PhD
Phone
86-531-67626996
Email
zhx87520052@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ligang Xing, MD, PhD
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanxi Zhao, MD
Phone
86-531-67626996
Email
zhx87520052@163.com
12. IPD Sharing Statement
Learn more about this trial
Oxygen Atomizing Inhalation of EGCG in the Treatment Interstitial Pneumonia in Cancer Patients
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