Gastrointestinal Adverse Reactions After Radiotherapy for Abdominopelvic Malignancies
Conditions
Interventions
Experimental Group A:Abdominal radiotherapy + Acupuncture
Control Group B:Abdominal radiotherapy + Sham acupuncture
Conventional Group C:Conventional treatment
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years; 2) Patients with radiotherapy indications scheduled for abdominopelvic radiotherapy; 3) ECOG score 0-1; 4) Child-Pugh score 5-7; 5) Hematological, hepatic, and renal functions meeting criteria: a) Neutrophil count =1.5×10^9/L b) Platelet count =75×10^9/L c) Hemoglobin =90g/L d) Serum albumin =30g/L e) Total bilirubin =50µmol/L f) AST/ALT <5×ULN; ALP <4×ULN g) INR =2.3 h) Creatinine <1.5×ULN 6) Signed informed consent 7) No active gastrointestinal symptoms (CTCAE v5.0 grade 0) or discontinuation of antiemetics/antidiarrheals =1 week pre-radiotherapy 8) Antibiotic-free =4 weeks.
Exclusion criteria
Exclusion criteria: 1) Concurrent malignancies or history within 5 years; 2) Prior thoracic/abdominal radiotherapy or acupuncture; 3) Pregnancy, lactation, or family planning within 2 years; 4) Severe cardiac/renal dysfunction: arrhythmias (requiring medication/pacemaker), uncontrolled hypertension, myocardial infarction within 6 months, QTc >450ms, NYHA class >II heart failure; 5) Coagulopathy, local skin infections, or acupuncture intolerance; 6) Severe comorbidities: alcoholism, substance abuse, psychiatric disorders affecting compliance; 7) Inflammatory bowel disease, intestinal obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow suppression status;Myelosuppression;Quality of life; | — |
Countries
China
Contacts
Public ContactZhang Shijun
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed