XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)

Launched by GUANGZHOU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Sep 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a traditional Chinese medicine called Xiao Chai Hu Tang (XCHT) to see if it can help patients who experience severe diarrhea caused by a chemotherapy drug called irinotecan. The trial will compare the effects of XCHT to a placebo (a treatment that looks the same but has no active ingredients) to see if it can reduce this troublesome side effect. The researchers are also looking at a specific substance in the blood to understand how well the body processes certain medications.

To participate in this trial, you must be an adult between 18 and 75 years old with a confirmed cancer diagnosis and have experienced significant diarrhea from irinotecan chemotherapy within the last month. You should also be in generally good health, with normal blood and organ function. If you join, you'll be closely monitored and asked to complete some questionnaires throughout the study. This is an opportunity to contribute to research that could help improve treatment for others facing similar challenges.

Gender

ALL

Eligibility criteria

• 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 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
• 6. Normal organ functions which can meet the requirements for systemic chemotherapy:
• • Normal bone marrow function: 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; AST \& ALT ≤ 5 × ULN if abnormal hepatic functions are caused by a potentially malignant tumor.
• • 7. Patients who can understand and complete the questionnaires in the case report form;
• • 8. Patients who 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 who has previously received radiotherapy on the abdominal cavity or pelvic cavity;
• • 5. Pregnant or lactating women;
• • 6. Patient who previously had or is now having thromboembolic events.