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

NARecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 8, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

December 1, 2026

Conditions
Xiao Chai Hu TangIrinotecan-induced Diarrhea
Interventions
DRUG

Xiao Chai Hu Tang (XCHT)

XCHT 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, for 3 cycles of chemotherapy.

DRUG

Placebo

Placebo 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, for 3 cycles of chemotherapy.

DRUG

Irinotecan regimen

"Patients will receive 3 cycles of irinotecan chemotherapy. FOLFIRI regimen:irinotecan (180 mg/m2) intravenous (IV) for over 90 minutes on Day 1. Folinic acid (400 mg/m2) IV over 2 hours on Day 1. 5-fluorouracil (5-FU) IV bolus (400 mg/m2) over 5 minutes on Day 1, followed by 5-FU (2400 mg/m2) IV continuously for 46-48 hours. Every 2 weeks.~mXELIRI regimen:irinotecan (200 mg/m2) intravenous (IV) for over 90 minutes on Day 1. Capecitabine (800 mg/m²) PO bid on day 1-14. Every 3 weeks.~CapIRI regimen:irinotecan (180 mg/m2) intravenous (IV) for over 90 minutes on Day 1. Capecitabine (1000 mg/m²) PO bid on day 1-14. Every 3 weeks.~FOLFOXIRI regimen:irinotecan (165 mg/m2) intravenous (IV) for over 90 minutes on Day 1. Oxaliplatin (85 mg/m2) intravenous (IV) for over 2 hours on Day 1.Folinic acid (400 mg/m2) IV over 2 hours on Day 1, followed by 5-FU (2400 - 3200 mg/m2) IV continuously for 48 hours. Every 2 weeks."

OTHER

Raloxifene

Raloxifene 60mg po, used as probe for pharmacokinetic testing, on Day 3 (the day before chemotherapy), for 3 cycles of chemotherapy.

Trial Locations (1)

510120

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou

All Listed Sponsors
collaborator

University of Houston

OTHER

lead

Guangzhou University of Traditional Chinese Medicine

OTHER