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

Phase 2

• Conditions: Esophagitis; Prevention & Control; Lung Neoplasms; Epigallocatechin Gallate
• Interventions: Drug: mLDG; Drug: EGCG

• Registration Number: NCT02577393
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-16
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28
• Primary Completion: 2022-06
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional therapy group	mLDG	-
prophylactic EGCG group	EGCG	-
therapeutic EGCG group	EGCG	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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