The effect of IV iron on the gut microbiome in patients with metastatic colorectal cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007895
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
? Signed written informed consent obtained prior to the study
? Men and women ? 19 years of age
? Eastern Cooperative Oncology Group(ECOG) Performance Status 0 ~ 2
? Histologically confirmed colorectal adenocarcinoma
? Treatment naive patients scheduled to undergo 1L FOLFOX-based palliative chemotherapy
? Hb 8.0-11.0g/dL
? Life expectancy ? 3months
? History of receiving iron supplements(oral or intravenous), erythropoiesis-stimulating agents(ESA), tranfusion, hemodialysis within 4 weeks
? Any severe infection within 28 days prior to study start
? Ongoing bleeding
? Bone marrow infiltration by the cancer
? Serum AST and ALT ? 3.5 * upper limit of normal(ULN)
? Hypersensitivity to ferrous sulfate
? Anemia other than iron-deficiency anemia
? Patients with ron overload(Ferritin > 800ng/ml, Transferrin saturation ? 50%) or disorders of iron metabolism
? Pregnancy or Breastfeeding
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of the diversity and composition of the gut microbiome by 16S rRNA sequencing
- Secondary Outcome Measures
Name Time Method The change of hemoglobin;The mean change of Fe, Ferritin, TIBC;Analysis of the change of gut and systemic metabolome;Treatment-related adverse events graded according to NCI CTCAE version 5.0.;Quality of life assessed by EORTC QLQ-C10