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

ConditionsXiao Chai Hu TangIrinotecan-induced Diarrhea
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Xiao Chai Hu Tang (XCHT)

    Drug

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

  • Placebo

    Drug

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

  • Irinotecan regimen

    Drug

    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.

  • Raloxifene

    Other intervention

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

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: XCHT groupExperimental treatment 3 interventions
Group B: Placebo groupPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of diarrhea (grade ≥2)

The diarrhea severity will be evaluated following standard criteria in NCI-CTC AE 5.0 Grade 2 is defined as Stool is increased by 4-6 times each day relative to baseline; discharge from stoma moderately increased.

Time frame
Through study completion, an average of 2 months

Secondary outcomes

1

Incidence of diarrhea (grade ≥3)

The diarrhea severity will be evaluated following standard criteria in NCI-CTC AE 5.0

Time frame
Through study completion, an average of 2 months
2

Incidence of other chemo-related adverse effects

Other adverse reactions will be evaluated following standard criteria in NCI-CTC AE 5.0

Time frame
Through study completion, an average of 2 months
3

Occult blood test for stool

Occult blood test for stool, reported as negative, weak positive, and positive.

Time frame
Through study completion, an average of 2 months
4

PK parameters(Cmax)

Cmax ,if with complete data, in each cycle of Cmax for XCHT and their metabolites (14 compounds) and intestinal UGT enzyme probe (raloxifene and metabolites)

Time frame
The blood samples (2.0 ml) will be collected at 4 points for each cycle(hour 0, hour 1, hour 2, hour 4 after raloxifene administration)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangzhou University of Traditional Chinese Medicine

Lead sponsor

University of Houston

Collaborator

Source ClinicalTrials.gov
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