Clinical trial · Interventional
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epigallocatechin Gallate | — | UNRESOLVED | — |
| Esophagitis | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prevention & Control | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGCG | Drug | — | UNRESOLVED |
| mLDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- prophylactic EGCG group
- interventionNames
- Drug: EGCG
- type
- EXPERIMENTAL
- label
- therapeutic EGCG group
- interventionNames
- Drug: EGCG
- type
- PLACEBO_COMPARATOR
- label
- conventional therapy group
- interventionNames
- Drug: mLDG
Primary outcomes (1)
- measure
- Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available