CompletedNot Applicable

XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study)

China24 participantsStarted 2021-07-16

Plain-language summary

Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Malignant tumor confirmed by histology or cytology;
. Postmenopausal women, after bilateral oophorectomy; age \> 60 years old, or age \< 60 years old with menopause for more than 1 year;
. Age ≥ 18 years old, ≤ 75 years old;
. ECOG score of the patient ≤ 2 points;
. Never been treated with irinotecan;
. Plan to receive at least 3 rounds of FOLFIRI chemotherapy determined by physicians;
. Normal organ functions can meet the requirements for systemic chemotherapy:
. Patient is willing to participate and cooperate to complete the questions in the case report form;

Exclusion criteria

. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Average trajectory of irinotecan, raloxifene, XCHT and their metabolites (14 compounds)

Timeframe: The blood samples (2.0 ml) will be collected at 8 points for each Round (hour 0, hour 0.5, hour 1, hour 2, hour 4, hour 6, hour 8, and hour 24 after raloxifene administration)

Trial details

NCT IDNCT04926545

SponsorGuangzhou University of Traditional Chinese Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-20

View on ClinicalTrials.gov More Malignant Tumor trials