None listed
Conditions
Interventions
Drug : Experimental: Intravenous iron group
Single-dose intravenous infusion of 1000mg iron isomaltoside (MonoFer®)
baseline, after 6 weeks, and 12 weeks. total 3 times.
Active Comparator: Oral iron
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults over 19 years of age - Subjects were diagnosed with metastatic colorectal cancer before participating in the study and were scheduled for chemotherapy or were currently undergoing chemotherapy with first (1st line) or second (2nd line) treatment drugs - Subjects whose hemoglobin level is within the range of 8.0-11 g/dL, or who have experienced a decrease in hemoglobin of 2 g/dL or more during chemotherapy - Ability to write/submit an informed consent form before participating in study
Exclusion criteria
Exclusion criteria: - History of receiving iron supplements(oral or intravenous), erythropoiesis-stimulating agents(ESA), tranfusion, hemodialysis within 4 weeks - Severe infection within 28 days prior to initiation of study - Ongoing bleeding - Deteriorated organ function: PI or Sub-i decision - ECOG performance status 3-4 - IV iron formulations and components of the formulations, if there is a significant hypersensitivity to other parenteral iron preparations - Any other anemia except iron deficiency anemia - Patients with iron overload or disorders of iron metabolism - Pregnancy or Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood results(Hb, iron, TSAT, TIBC, sTFR, hepcidin, rediculocyte) | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of hemoglobin;The change of anemia-related laboratory results;Quality of life assessed by EORTC QLQ-C10;Treatment-related adverse events graded according to NCI CTCAE version 5.0.;changes in microbiome metabolomics | — |
Countries
Korea, Republic of
Contacts
Public Contactlee soohyeon
Korea University Anam Hospital
Outcome results
None listed