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

Lung Neoplasms Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02577393
• Other study ID #: GTEEC-2015
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: August 2022

Study information

• Verified date: April 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 83
• Est. completion date: August 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epigallocatechin Gallate
• Esophagitis
• Lung Neoplasms
• Prevention & Control

Intervention

Drug:
• EGCG
EGCG (purity=95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.
• EGCG
EGCG (purity=95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
• mLDG
mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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