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

RecruitingNAAges 18 Years - 75 YearsAllGuangzhou University of Traditional Chinese Medic…
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In plain words

What the trial is, and whether it could suit you

Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Xiao Chai Hu Tang (XCHT)
  • Placebo
  • Irinotecan regimen
  • Raloxifene
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Where

1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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