Radiation esophagitis
Conditions
Interventions
Trial Group:5% Dextrose Injection 100ml + Jishuanghua Formula (Baiji 15g, Shihuang 30g, Tianhuafen 20g, JinYinhua 20g, Chonglou 9g, Shengdi Huang 15g, Zicao 15g, Sanqi 6g) intravenous drip, once daily
Control Group:5% Dextrose Injection 100ml + Dexamethasone 5mg intravenous drip, once daily
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with esophageal cancer diagnosed by pathology or cytology 2. aged 18 to 80 years old, men and women not limited 3. ECOG score 0 to 2 points 4. is expected to survival or 6 months 5. Patients scheduled for esophageal radiotherapy including preoperative radiotherapy, radical radiotherapy, and concurrent chemoradiotherapy; 6. voluntarily participate in this research, and has set up a signed informed consent form, will be effected according to the doctor's advice adhere to medication, good adherence, cooperate to follow-up.
Exclusion criteria
Exclusion criteria: 1. Those with a history of upper gastrointestinal bleeding or perforation; 2. Patients who have undergone or are planning to undergo esophageal cancer surgery; 3. Pregnant or lactating women; 4. Those who are completely unable to eat due to difficulty in swallowing; 5. Other conditions that the researchers consider to prevent patients from participating in this trial include, but are not limited to, severe and uncontrollable organic lesions or infections, unstable angina pectoris, congestive heart failure, etc. Those with severe liver and kidney dysfunction (serum creatinine, ALT or AST, bilirubin >=1.5 times ULN); Patients with mental illnesses or mental disorders accompanied by symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute radiation esophagitis (ARE);Incidence of severe acute radiation esophagitis (SARE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade of radiation esophagitis;Duration of radiation esophagitis;Onset time of radiation esophagitis;Performance status score;Pain score (Numerical Rating Scale, NRS);Weight change before and after radiotherapy;Quality of life (QOL) score;Clinical symptom score;Traditional Chinese medicine syndrome elements;Inflammatory markers;Immune markers;Biomarkers of oxidative stress and antioxidant capacity;Intestinal microbiota composition; | — |
Countries
China
Contacts
Public ContactZhao Biao
Sichuan Cancer Hospital
Outcome results
None listed