XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study)

This is an interventional basic science trial for Malignant Tumor focused on measuring Malignant tumor, Irinotecan, chemotherapy-induced diarrhea, Classical Chinese Formula, safety Read More

Cohort A: Naïve (no irinotecan treatment before) postmenopausal female cancer patients.

Inclusion criteria:

1. Malignant tumor confirmed by histology or cytology;
2. Postmenopausal women, after bilateral oophorectomy; age > 60 years old, or age < 60 years old with menopause for more than 1 year;
3. Age ≥ 18 years old, ≤ 75 years old;
4. ECOG score of the patient ≤ 2 points;
5. Never been treated with irinotecan;
6. Plan to receive at least 3 rounds of FOLFIRI chemotherapy determined by physicians;

7. Normal organ functions can meet the requirements for systemic chemotherapy:

   • Reserve functions of normal bone marrow: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90 g/L;
   • Normal renal functions: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min;
   • Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) & alanine aminotransferase (ALT) ≤ 2.5 × ULN; If abnormal hepatic functions are caused by a potentially malignant tumor, and AST ＆ ALT ≤ 5 × ULN;
8. Patient is willing to participate and cooperate to complete the questions in the case report form;
9. Patient can understand and sign the informed consent form, is well compliant, and can be followed up.

Cohort B: cancer patients who experienced irinotecan -induced diarrhea (grade >2)

Inclusion criteria:

1. Malignant tumor confirmed by histology or cytology;
2. Age ≥ 18 years old, ≤ 75 years old;
3. ECOG score of the patient ≤ 2 points;
4. Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
5. Patients who plan to receive 3 rounds of FOLFIRI chemotherapy;

6. Normal organ functions can meet the requirements for systemic chemotherapy:

   • Reserve functions of normal bone marrow: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90g/L;
   • Normal renal functions: serum creatinine ≤ 1.5mg/dl (133μmol/L) and/or creatinine clearance ≥ 60ml/min;
   • Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) & alanine aminotransferase (ALT) ≤ 2.5 × ULN; If abnormal hepatic functions are caused by a potentially malignant tumor, and AST ＆ ALT ≤ 5 × ULN;
7. Patient is willing to participate and cooperate to complete the questions in the case report form;
8. Patients can understand and sign the informed consent form, is well compliant, and can be followed up.

Exclusion Criteria:

1. Patients with diagnosed depression, obsession or/and schizophrenia;
2. Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
3. Patient with active tuberculosis and other uncontrolled infections;
4. Patient has previously received radiotherapy on the abdominal cavity and pelvic cavity;
5. Pregnant or lactating women;
6. Patient previously had or is now having thromboembolic (blood clotting) events.