NCT05039983CompletedPhase 1
Study of Epigallocatechin-3-gallate (EGCG) for Supportive and Symptomatic Management in Patients With Esophageal Cancer
Source: ClinicalTrials.gov · Last updated 3 Apr 2024
Brief summary (registry, in English)
The main symptom of patients with advanced esophageal cancer is eating obstruction. In clinical practice, patients need to wait for a long time before anti-tumor treatment, which will lead to a rapid decline in the quality of life and nutritional status of patients, and severe patients sometimes need to place nasointestinal feeding tubes or endoscopic stents. EGCG has been shown to have antioxidant, anti-inflammatory and anti-tumor effects . The complex effects of EGCG may improve esophageal obstruction during the waiting period before antineoplastic therapy. The purpose of this phase I study was to explore the safety, recommended dose and preliminary efficacy of EGCG solution in the treatment of esophageal obstruction.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 22 Aug 2021
- Start date
- 20 Aug 2021
- Primary completion date
- 27 Dec 2023
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05039983
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 18
- From 20 Aug 2021 to the primary completion date, 27 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- known hypersensitivity or allergy to any kind green tea extract
Other
- lactating or pregnant women
- placement of small intestinal feeding tube or endoscopic stent treatment
- unable or refusing to take oral liquids
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shan Dong cancer hospital and institute Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.