To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
NCT ID:
NCT06398405
Condition:
Esophageal Cancer
Dysphagia, Esophageal
Epigallocatechin Gallate
Conditions: Official terms:
Esophageal Neoplasms
Deglutition Disorders
Epigallocatechin gallate
Conditions: Keywords:
Esophageal Cancer
Dysphagia, Esophageal
Epigallocatechin gallate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Epigallocatechin-3-gallate
Description:
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400
umol/L
Arm group label:
EGCG ARM
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanxi Zhao, MD
Phone:
86-531-67626996
Email:
zhx87520052@163.com
Start date:
April 22, 2024
Completion date:
May 22, 2026
Lead sponsor:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06398405
