Status:
RECRUITING
XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
Lead Sponsor:
Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsors:
University of Houston
Conditions:
Xiao Chai Hu Tang
Irinotecan-induced Diarrhea
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 plas...
Detailed Description
A total of 98 patients, who are planning to recieve at least 3 cycles of irinotecan chemotherapy, will be randomly assigned, at a 1:1 ratio, to XCHT group or placebo group, using a central randomizati...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Malignant tumor confirmed by histology or cytology;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
- Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
- 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.
- Patients who can understand and complete the questionnaires in the case report form;
- Patients who can understand and sign the informed consent form, is well compliant, and can be followed up.
- Exclusion Criteria:
- Patients with diagnosed depression, obsession or/and schizophrenia;
- Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
- Patient with active tuberculosis and other uncontrolled infections;
- Patient who has previously received radiotherapy on the abdominal cavity or pelvic cavity;
- Pregnant or lactating women;
- Patient who previously had or is now having thromboembolic events.
Exclusion
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06055179
Start Date
March 8 2024
End Date
December 1 2026
Last Update
July 1 2025
Active Locations (1)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120