Using Xiao Chai Hu Tang to prevent diarrhea from irinotecan chemotherapy
Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang (XCHT) Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Randomized Controlled Trial)
This study is testing whether a traditional herbal remedy called Xiao Chai Hu Tang can help prevent severe diarrhea in cancer patients receiving irinotecan chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Guangzhou University of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06055179 on ClinicalTrials.gov |
What this trial studies
This randomized double-blind placebo-controlled trial aims to evaluate the effectiveness of Xiao Chai Hu Tang (XCHT) in preventing severe delayed-onset diarrhea caused by irinotecan chemotherapy in patients with malignant tumors. A total of 98 participants will be randomly assigned to receive either XCHT or a placebo for five days during each of three chemotherapy cycles, starting three days prior to the chemotherapy. The study will also assess the pharmacokinetic profile of various compounds related to the treatment and validate a specific probe for intestinal activity. The primary focus is on the safety and efficacy of XCHT in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed malignant tumors who experience grade 2 or worse diarrhea from irinotecan and plan to receive at least three cycles of this chemotherapy.
Not a fit: Patients who do not have irinotecan-induced diarrhea or those with severe comorbidities affecting their ability to tolerate chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of debilitating diarrhea in patients undergoing irinotecan chemotherapy.
How similar studies have performed: While the use of traditional Chinese medicine in conjunction with chemotherapy is gaining interest, this specific approach has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Haibo Zhang, Prof. — Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study coordinator: Yanjuan Zhu, Dr.
- Email: zyjsophy@gzucm.edu.cn
- Phone: 86 20 81887233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.