Anemia, Cancer
Conditions
Brief summary
* Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple. * Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment. * Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone. * In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
Interventions
DRUGFerinject®
intravenous Ferinject 1000mg injection
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who diagnosed with solid cancer or lymphoma * Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment * anticancer therapy: chemotherapy, and/or chemotherapy + radiotherapy, and/or target agent * Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment
Exclusion criteria
* Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment * Subjects with uncontrolled infection * Subjects with ongoing bleeding * Deteriorated organ function * poor performance state (ECOG 3-4) * Subjects whose disease involves bone marrow * Ferritin \> 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Hemoglobin response | visit 4th after Ferinject injection |
Countries
South Korea
Outcome results
None listed