XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborator: University of Houston
• Treatments: Raloxifene Hydrochloride

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 FOLFIRI/mXELIRI chemotherapy;

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.