Dysphagia, Esophageal, Epigallocatechin Gallate, Esophageal Cancer
Conditions
Keywords
Esophageal Cancer, Dysphagia, Esophageal, Epigallocatechin gallate
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.
Interventions
Epigallocatechin-3-gallate is administered in a solution with a concentration of 4400 umol/L
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Choking symptom objective response rate | baseline and up to 7 days post-treatment | Choking when swallowing was assessed by Stooler's dysphagia score (0-4, with 0 being none and 4 being completely unable to feed orally) |
| Pain symptom objective response rate | baseline and up to 7 days post-treatment | Pain when swallowing was assessed by numerical rating scale (0-5, with 0 being none and 5 being worst pain imaginable) |
| Imaging objective response rate | Change from Baseline esophageal stenosis size at 7 days | Response rate of esophageal stenosis was determined by X-ray barium meal examination and/or contrast-enhanced CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prealbumin change | baseline and up to 7 days post-treatment | The prealbumin values were tested by biochemical analysis |
| Albumin change | baseline and up to 7 days post-treatment | The albumin values were tested by biochemical analysis |
| Number of Participants with Adverse Events | baseline and up to 7 days post-treatment | participants will be followed for the duration of EGCG treatment |
Countries
China
Outcome results
None listed