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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L
Shandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGChoking 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)
Time frame: 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)
Time frame: 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
Time frame: Change from Baseline esophageal stenosis size at 7 days
prealbumin change
The prealbumin values were tested by biochemical analysis
Time frame: baseline and up to 7 days post-treatment
Albumin change
The albumin values were tested by biochemical analysis
Time frame: baseline and up to 7 days post-treatment
Number of Participants with Adverse Events
participants will be followed for the duration of EGCG treatment
Time frame: baseline and up to 7 days post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.