XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou University of Traditional Chinese Medicine
About this trial
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
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Xiao Chai Hu Tang (XCHT)
- Placebo
- Irinotecan regimen
- Raloxifene
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guangzhou University of Traditional Chinese Medicine
Lead sponsor
University of Houston
Collaborator
Source ClinicalTrials.gov