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

NCT06398405 | Recruiting Phase 2

• 1 other identifier: GTEEC2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Dysphagia, Esophageal; Epigallocatechin Gallate

Keywords

Esophageal Cancer; Dysphagia, Esophageal; Epigallocatechin gallate

Outcome Measures

Primary Outcomes (3)

• Choking symptom objective response rate

  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

  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

• Imaging objective response rate

  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

Secondary Outcomes (3)

• prealbumin change

  baseline and up to 7 days post-treatment

• Albumin change

  baseline and up to 7 days post-treatment

• Number of Participants with Adverse Events

  baseline and up to 7 days post-treatment

Study Arms (1)

EGCG ARM

EXPERIMENTAL

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

Interventions

Epigallocatechin-3-gallate OTHER

Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L

EGCG ARM

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Deglutition Disorders

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: April 22, 2024
• Primary Completion: April 22, 2026
• Study Completion (Estimated): May 22, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

CN (1)