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

NCT06055179 ↗

Recruiting 98 enrolled Guangzhou University of Traditional Chinese Medicine University of Houston · collab
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2024-03-08
Primary completion
2026-06-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Raloxifene Other / unclassified 60 mg Oral
Subject Xiao Chai Hu Tang Traditional medicine (herbal / TCM) 9 g Oral
Background Capecitabine Small molecule 800 mg/m2 Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Irinotecan Small molecule 165 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background Irinotecan Small molecule 200 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous
Background fluorouracil Small molecule 3200 mg/m2 Intravenous

Indications

irinotecan toxicity