A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer

May 2, 2024 updated by: Han Xi Zhao, Shandong Cancer Hospital and Institute

Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial

The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • confirmed pathological esophageal squamous cell carcinoma
  • ≥18 years old
  • the Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
  • no previous anti-tumor treatment
  • no esophageal bleeding or fistula
  • adequate hemocyte count, normal hepatic and renal functions
  • Esophageal obstruction classified as grade 2 or grade 3 according to Stooler's dysphagia score

Exclusion Criteria:

  • lactating or pregnant women
  • known hypersensitivity or allergy to any kind green tea extract
  • placement of small intestinal feeding tube or endoscopic stent treatment
  • unable or refusing to take oral liquids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGCG ARM
Studies investigating EGCG (purity 95% by high-performance liquid chromatography, obtained from Zhejiang Ningbo HEP Biotech Co., Ltd.) utilized a concentration of 4400 umol/L dissolved in 0.9% saline solution, which is administered three times a day for 1 week. Freshly prepared each time, the EGCG was administered 10 minutes before meals. The repeated slow swallowing of 30 ml of the EGCG solution was essential to ensure sustained contact of the drug on the esophageal walls
Other: Epigallocatechin-3-gallate
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging objective response rate
Time Frame: Change from Baseline esophageal stenosis size at 7 days
Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT
Change from Baseline esophageal stenosis size at 7 days
Choking symptom objective response rate
Time Frame: baseline and up to 7 days post-treatment
Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally)
baseline and up to 7 days post-treatment
Pain symptom objective response rate
Time Frame: baseline and up to 7 days post-treatment
Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable)
baseline and up to 7 days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prealbumin change
Time Frame: baseline and up to 7 days post-treatment
The prealbumin values were tested by biochemical analysis
baseline and up to 7 days post-treatment
Albumin change
Time Frame: baseline and up to 7 days post-treatment
The albumin values were tested by biochemical analysis
baseline and up to 7 days post-treatment
Number of Participants with Adverse Events
Time Frame: baseline and up to 7 days post-treatment
participants will be followed for the duration of EGCG treatment
baseline and up to 7 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

April 22, 2026

Study Completion (Estimated)

May 22, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTEEC2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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