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

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

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.

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