A Phase II Clinical Study of Epigallocatechin-3-gallate in Patients With Esophageal Squamous Cancer
Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial
Shandong Cancer Hospital and Institute
72 participants
Apr 22, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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
Interventions
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06398405