Solid Tumor Patients
Conditions
Interventions
Study Group:Berberine
Control group:Placebo
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed solid tumors; 2. Age >= 18 years old; 3. The patient's physical condition is ECOG performance status =125mg/m²); 6. Bone marrow functional requirements: Absolute neutrophil count (ANC) >= 1.5 × 10?/L, platelet count (PLT) 125 >= 100 × 10?/L, hemoglobin (HGB) >= 90g/L; 7. Renal function requirement: Serum creatinine =60ml/min; 8. Liver function requirements: Serum total bilirubin <= 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN; if there is potential liver dysfunction caused by malignancy, AST and ALT must be <= 5×ULN. 9. Patients who can understand and complete the questionnaire in the case report form; 10. Patients who can understand and sign the informed consent form, have good compliance, and are willing to accept follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with diarrhea caused by tumors, immunotherapy, targeted therapy, radiotherapy, malabsorption of fat, ischemic colitis, overflow diarrhea, diarrhea caused by surgery, enteral feeding, etc. 2. Patients diagnosed with depression, obsessive-compulsive disorder and/or schizophrenia; 3. Patients diagnosed with inflammatory bowel disease (including Crohn's disease and ulcerative colitis); 4. Patients with active pulmonary tuberculosis or other uncontrolled infectious diseases; 5. Patients who have received abdominal or pelvic radiotherapy within the past 3 months; 6. Patients who have had or are currently experiencing thromboembolic events. 7. Patients who have not taken non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics or probiotics within two weeks before treatment; 8. Those who participate in other clinical research treatments simultaneously and may affect the observation of the effect indicators in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade >=2 Diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Grade >=3 Diarrhea;Time to First Occurrence and Duration of Grade >=2 Diarrhea;Maximum Number of Bowel Movements;Bristol Stool Scale;Duration and Dose of Loperamide Rescue Therapy;Distribution of Diarrhea by Grade; | — |
Countries
China
Contacts
Public ContactQinghua Yao
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed