drugset / Trial / NCT02577393

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

NCT02577393

Phase 2 Unknown 83 enrolled Shandong Cancer Hospital and Institute
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2015-04
Primary completion
2022-06
Completion
2022-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.02 mg/ml Oral
Subject Epigallocatechin gallate Small molecule 0.44 mmol Oral
Subject Gentamicin Small molecule 0.16 mg/ml Oral
Subject Lidocaine Other / unclassified 0.16 mg/ml Oral