- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577393
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
April 25, 2020 updated by: Han Xi Zhao, Shandong Cancer Hospital and Institute
The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy.
In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system.
Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy.
The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
83
Phase
- Phase 2
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pathologically documented LC
- considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer
- age ≥18 years
- Karnofsky ≥70
- adequate hematologic, hepatic and renal function
- FEV1 > 800 cc
- mean esophagus dose >20 Gy
Exclusion criteria were as follows:
- a known allergy or hypersensitivity to EGCG
- pregnancy or lactation
- prior radiation to the thorax
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: prophylactic EGCG group
|
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day.
A new batch is made up each time.
For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.
We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study.
Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed.
Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day.
A new batch is made up each time.
For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.
We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study.
Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
|
Experimental: therapeutic EGCG group
|
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day.
A new batch is made up each time.
For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.
We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study.
Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed.
Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.
EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day.
A new batch is made up each time.
For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.
We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study.
Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
|
Placebo Comparator: conventional therapy group
|
mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day.
Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
Time Frame: Each patient will be enrolled for a 8-9 week trial
|
Each patient will be enrolled for a 8-9 week trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation
Time Frame: Each patient will be enrolled for a 8-9 week trial
|
Each patient will be enrolled for a 8-9 week trial
|
Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.
Time Frame: Each patient will be enrolled for a 8-9 week trial
|
Each patient will be enrolled for a 8-9 week trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2015
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
September 28, 2015
First Submitted That Met QC Criteria
October 13, 2015
First Posted (Estimate)
October 16, 2015
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 25, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Gastroenteritis
- Esophageal Diseases
- Lung Neoplasms
- Esophagitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Antimutagenic Agents
- Epigallocatechin gallate
Other Study ID Numbers
- GTEEC-2015
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 Lung Neoplasms
-
UNC Lineberger Comprehensive Cancer CenterSivan Innovation Ltd.CompletedLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of LungUnited States
-
Baptist Health South FloridaWithdrawnLung Cancer | Lung TumorUnited States
-
Oliver JonasMassachusetts General HospitalCompletedLung Cancer | Lung TumorUnited States
-
C. R. BardCompleted
-
Portsmouth Hospitals NHS TrustCompletedLung Cancer | Interstitial Lung DiseaseUnited Kingdom
-
Azienda Sanitaria-Universitaria Integrata di UdineRecruitingLung Diseases | Lung Cancer | Lung Adenocarcinoma | Lung Transplant Rejection | Lung; Node | Lung TBItaly
-
Point TherapeuticsTerminatedCarcinoma, Non-Small-Cell Lung | Lung Cancer | Neoplasms, Lung | Neoplasms, PulmonaryUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Keimyung University Dongsan Medical CenterCompletedLung Cancer | Lung Diseases, Interstitial
-
Mayo ClinicMedtronic - MITGTerminatedLung Neoplasms | Lung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of Lung | Cancer of the Lung | Metastatic Cancer to the LungUnited States
Clinical Trials on EGCG
-
Hal ChapmanMassachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI) and other collaboratorsRecruitingIdiopathic Pulmonary FibrosisUnited States
-
Shandong Cancer Hospital and InstituteUnknownEpigallocatechin Gallate | Radiation Mucositis | Radio Dermatitis
-
Dr. Johannes LevinGerman Center for Neurodegenerative Diseases (DZNE); Deutsche Parkinson Vereinigung and other collaboratorsCompletedMultiple System AtrophyGermany
-
Shandong Cancer Hospital and InstituteRecruiting
-
Louisiana State University Health Sciences Center...Polyphenon PharmaCompleted
-
Northumbria UniversityCompletedCognitive Function | MoodUnited Kingdom
-
Shandong Cancer Hospital and InstituteRecruitingNeoplasms Malignant | Interstitial PneumoniaChina
-
Shandong Cancer Hospital and InstituteUnknownBreast Neoplasms | Dermatitis | Prevention & Control | Epigallocatechin Gallate
-
Xuanwu Hospital, BeijingMinistry of Health, China; Michael J. Fox Foundation for Parkinson's ResearchCompletedParkinson's DiseaseChina
-
National Yang Ming UniversityTaipei City HospitalUnknown