Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin-3-gallate | Other | Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| prealbumin change | The prealbumin values were tested by biochemical analysis | baseline and up to 7 days post-treatment |
| Albumin change | The albumin values were tested by biochemical analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline and up to 7 days post-treatment |
| Number of Participants with Adverse Events | participants will be followed for the duration of EGCG treatment | baseline and up to 7 days post-treatment |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |