A Randomized, Multicenter, Open-label Clinical Study to Compare the Efficacy of Intravenous to Oral Iron on Anemia Treatment
- Conditions
- Neoplasms
- Registration Number
- KCT0008125
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 316
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
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method blood results(Hb, iron, TSAT, TIBC, sTFR, hepcidin, rediculocyte)
- Secondary Outcome Measures
Name Time Method 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