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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborator: University of Houston
• Treatments: Fluorouracil; Irinotecan; Raloxifene Hydrochloride

Criteria

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.