Chinese Herbal Formula Xingqi Zhitong for Acute Radiation-Induced Esophagitis in Esophageal Cancer: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial
- Conditions
- acute radiation-induced esophagitis
- Registration Number
- ITMCTR2100004535
- Lead Sponsor
- Shanxi Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Those with a confirmed diagnosis of esophageal squamous cell carcinoma by gastroscopy and pathological cytohistology (AJCC 8th edition).
2. Age greater than 18 years.
3. Patients without indications for surgery or refusing surgery.
4. No previous radiation therapy.
5. No contraindication to radiation therapy.
6. ECOG (Eastern Cooperative Oncology Group) score 0-2.
7. Those with expected survival time > 12 weeks.
8. Those who signed the informed consent form.
1. Complete esophageal obstruction, deep esophageal ulcer, esophageal perforation or vomiting of blood.
2. History of surgery within 28 days prior to baseline.
3. Participation in other interventional clinical trials within 30 days.
4. Pregnant and lactating women.
5. Those with severe cardiac, pulmonary, hepatic, or renal abnormalities, or immunodeficiency.
6. Those with uncontrollable psychiatric disorders, tumor metastatic disease (according to the AJCC 8th edition M1b).
7. Any other condition that the investigator deems the patient unsuitable for the clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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