Actively Recruiting
XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
Led by Guangzhou University of Traditional Chinese Medicine · Updated on 2025-07-01
98
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
G
Guangzhou University of Traditional Chinese Medicine
Lead Sponsor
U
University of Houston
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Malignant tumor confirmed by histology or cytology
- Age 18 years or older and 75 years or younger
- ECOG performance score of 2 points or less
- Experienced diarrhea worse than grade 2 due to irinotecan chemotherapy within the last month
- Planning to receive at least 3 cycles of irinotecan chemotherapy with dose 125 mg/m2 or higher
- Normal bone marrow function: neutrophil count ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L
- Normal kidney function: serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
- Normal liver function: total bilirubin ≤ 1.5 times upper normal limit, AST and ALT ≤ 2.5 times upper normal limit; if abnormal due to tumor, AST and ALT ≤ 5 times upper normal limit
- Able to understand and complete questionnaires
- Able to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Diagnosis of depression, obsession, or schizophrenia
- Diagnosis of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
- Active tuberculosis or other uncontrolled infections
- Previous radiotherapy to abdominal or pelvic area
- Pregnant or breastfeeding women
- History or current thromboembolic events
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
Y
Yanjuan Zhu, Dr.
CONTACT
Y
Yadong Chen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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