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

• Status: Enrolling by invitation
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Epigallocatechin gallate

Criteria

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