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Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer

NCT05039983 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-04-03

No results posted yet for this study

Summary

The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.

Conditions

  • Esophageal Obstruction

Interventions

OTHER

EGCG

EGCG use various concentrations dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 30 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2023-12-27
Completion
2024-01-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039983 on ClinicalTrials.gov