NCT06055179 XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
| NCT ID | NCT06055179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou University of Traditional Chinese Medicine |
| Condition | Xiao Chai Hu Tang |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-03-08 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2024-03-08 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.
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.
Contact & Investigator
Haibo Zhang, Prof.
PRINCIPAL INVESTIGATOR
Guangdong Provincial Hospital of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT06055179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Xiao Chai Hu Tang. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06055179 currently recruiting?
Yes, NCT06055179 is actively recruiting participants. Contact the research team at zyjsophy@gzucm.edu.cn for enrollment information.
Where is the NCT06055179 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06055179 clinical trial?
NCT06055179 is sponsored by Guangzhou University of Traditional Chinese Medicine. The principal investigator is Haibo Zhang, Prof. at Guangdong Provincial Hospital of Traditional Chinese Medicine. The trial plans to enroll 98 participants.