Evaluating Epigallocatechin-3-gallate for Esophageal Cancer Patients
Efficacy and Safety of Epigallocatechin-3-gallate, an Important Polyphenolic That Originates From Tea, in Patients With Esophageal Squamous Cancer: A Phase II Trial
This study is testing if a compound called EGCG can help people with esophageal cancer who have trouble swallowing feel better after a week of treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06398405 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study investigates the safety and effectiveness of Epigallocatechin-3-gallate (EGCG) in patients diagnosed with esophageal squamous cell carcinoma who experience dysphagia. Participants will undergo daily assessments of swallowing-related dysphagia and pain scores using a numerical rating scale, alongside barium meal radiography to measure luminal size and lesion length before and after one week of EGCG treatment. The study includes translated guides for proper assessment and scale usage in Chinese. The goal is to determine if EGCG can improve swallowing difficulties in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed esophageal squamous cell carcinoma and moderate to severe dysphagia.
Not a fit: Patients with prior anti-tumor treatments or those with esophageal bleeding or fistulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function and quality of life for patients with esophageal cancer.
How similar studies have performed: While the use of EGCG in cancer treatment is being explored, this specific application in esophageal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jinan, Shandong
- Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.