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Chinese Herbal Formula Xingqi Zhitong for Acute Radiation-Induced Esophagitis in Esophageal Cancer: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial

Chinese Herbal Formula Xingqi Zhitong for Acute Radiation-Induced Esophagitis in Esophageal Cancer: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043978
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute radiation-induced esophagitis

Interventions

Sponsors

Shanxi Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Incidence of acute radiation esophagitis;Clinical classification of acute radiation esophagitis;

Secondary

MeasureTime frame
The occurrence time and duration of acute radiation esophagitis;Pain index;Dysphagia;Quality of Life Score (QOL-C30);

Countries

China

Contacts

Public ContactXixing Wang

Shanxi Institute of Traditional Chinese Medicine

ggyy572216@163.com+86 13623618679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026