Radiation proctitis
Conditions
Interventions
Experimental Group:Combined use of Wen Qing Chang Kang Yin and conventional Western medical treatment.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients with histologically confirmed cervical cancer undergoing radiotherapy, staged as IB-IV (2019 FIGO staging); (2) Age: 18-70 years; (3) Meet the diagnostic criteria for acute radiation proctitis (refer to the Chinese Expert Consensus on the Integrated Traditional and Western Medicine Diagnosis and Treatment of Radiation-Induced Intestinal Injury (2023 Edition) and expert opinions); (4) No significant organ dysfunction and no history of major gastrointestinal diseases; (5) No history of antibiotic use within the past 2 weeks; (6) Laboratory tests prior to enrollment must meet the following conditions: 1) Liver function: Total bilirubin =1.5 × upper limit of normal (ULN); AST and ALT =2.5 × ULN; Alkaline phosphatase =1.5 × ULN; 2) Renal function: Creatinine clearance rate =80 mL/min; 3) Blood routine: Absolute neutrophil count (ANC) =2×10^9/L, platelet count =100×10^9/L, and hemoglobin =90 g/L; (7) Patients must voluntarily agree and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) History of rectal surgery or rectal invasion found before treatment; (2) Pregnant or breastfeeding women; (3) Patients with recurrent proctitis (more than once a month) before radiotherapy; (4) Patients receiving experimental treatment in other clinical studies (currently in the treatment phase of a clinical study or having participated in other drug clinical trials within the past 30 days).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation proctitis symptom scoring in traditional Chinese medicine;Post-radiotherapy reaction grading criteria (RTOG/EORTC) for assessment of radiation-induced intestinal injury grading changes.;Inflammatory cytokines: Interleukin-1ß (IL-1ß), IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, interferon gamma (IFN-?), and tumor necrosis factor alpha (TNF-a) levels.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scoring;Intestinal barrier function indicators: D-lactic acid, diamine oxidase (DAO), bacterial endotoxin;Chronic Food Allergy (IgG) Testing;Fecal Microbiota Testing; | — |
Countries
China
Contacts
Public ContactZhou Min
Jiangsu Cancer Hospital
Outcome results
None listed