None listed
Conditions
Interventions
Others(Dietary Supplement) : Patients with metastatic or unresectable colorectal or pancreatic cancer scheduled to receive irinotecan-based chemotherapy (FOLFIRI or mFOLFIRINOX) are randomized 1:1 to
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who voluntarily provide written informed consent to participate in this study 2) Adult men and women aged 19 years or older 3) ECOG performance status 0 or 1 4) Histologically confirmed metastatic or unresectable colorectal cancer or pancreatic cancer 5) Subjects scheduled to receive irinotecan-containing chemotherapy (FOLFIRI or mFOLFIRINOX) 6) Subjects who are not currently taking probiotic supplements, or who are able to discontinue probiotic use prior to study participation (enrollment permitted 1 week after discontinuation) 7) Hemoglobin >9.0 g/dL, neutrophil count >1,000/µL, platelet count >75,000/µL, serum creatinine <1.5 × upper limit of normal (ULN), AST/ALT <3 × ULN, total bilirubin <1.5 × ULN 8) Subjects who understand the nature of the clinical trial, are cooperative with study procedures, and are judged capable of participating until study completion
Exclusion criteria
Exclusion criteria: 1) Subjects who have undergone total colectomy or have an ileostomy 2) Patients currently receiving antibiotic treatment 3) Pregnant or lactating women 4) Subjects with uncontrolled infection or other concomitant systemic disease 5) Subjects with a known allergic reaction to the investigational product 6) Subjects judged by the investigator to be otherwise unsuitable for participation 7) Subjects with a previously confirmed UGT1A1*28 variant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of change from baseline (?AUC) in the summed score of seven gastrointestinal symptom items (pain, fatigue, appetite loss, nausea, vomiting, constipation, diarrhea) from the EORTC QLQ-C30 questionnaire, calculated using the trapezoidal rule | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Grade =2 delayed-onset diarrhea during irinotecan-based chemotherapy;Patient-reported outcomes: full and individual-item analysis of the EORTC QLQ-C30, and analysis of patient symptom and medication diaries;Antitumor response: overall response rate (ORR), progression-free survival (PFS), and overall survival (OS);Correlation between gut microbiome changes and incidence of gastrointestinal adverse events;Correlation between gut microbiome changes and chemotherapy response (antitumor effect and development of resistance) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyewon Han
Seoul National University Hospital
Outcome results
None listed