Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy

Study Overview
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Brief Summary
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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.

Conditions
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Esophagitis, Lung Neoplasms, Prevention & Control, Epigallocatechin Gallate

Intervention / Treatment
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* Drug: EGCG
* Drug: EGCG
* Drug: mLDG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prophylactic EGCG group<br> | Drug: EGCG<br>* 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.<br>|
| Experimental: therapeutic EGCG group<br> | Drug: EGCG<br>* 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.<br>|
| Placebo Comparator: conventional therapy group<br> | Drug: mLDG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation |  | Each patient will be enrolled for a 8-9 week trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation |  | 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. |  | Each patient will be enrolled for a 8-9 week trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Neoplasms, esophagitis, Prevention & Control, Epigallocatechin Gallate