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

Shandong First Medical University

Status and phase: Unknown; Phase 2

Conditions: Esophagitis; Lung Neoplasms; Epigallocatechin Gallate; Prevention & Control

Treatments: Drug: mLDG; Drug: EGCG

Study type: Interventional

Funder types: Other

Identifiers

NCT02577393

GTEEC-2015

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 3 patient groups, including a placebo group

prophylactic EGCG group

Experimental group

Treatment:

Drug: EGCG

Drug: EGCG

therapeutic EGCG group

Experimental group

Treatment:

Drug: EGCG

Drug: EGCG

conventional therapy group

Placebo Comparator group

Treatment:

Drug: mLDG