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

NCT02577393 | Unknown Phase 2

• 1 other identifier: GTEEC-2015
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Neoplasms; Esophagitis; Prevention & Control; Epigallocatechin Gallate

Keywords

Lung Neoplasms; esophagitis; Prevention & Control; Epigallocatechin Gallate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

prophylactic EGCG group

EXPERIMENTAL

Drug: EGCG

therapeutic EGCG group

EXPERIMENTAL

Drug: EGCG

conventional therapy group

PLACEBO COMPARATOR

Drug: mLDG

Interventions

EGCG DRUG

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.

prophylactic EGCG group

mLDG DRUG

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.

conventional therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• a known allergy or hypersensitivity to EGCG
• pregnancy or lactation
• prior radiation to the thorax

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Lung Neoplasms; Esophagitis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Ligang Xing, MD,PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 16, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 28, 2020

Record last verified: 2020-04