None listed
Conditions
Interventions
Drug : ? Combination therapy group:
- Ferric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes
Sponsors
Hallym University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patient who has signed a written consent ? Age = 19 ? Histologically diagnosed advanced/metastatic solid cancer ? Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study ? Anemia with functional iron deficiency 1) Hemoglobin <10g/dL 2) functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL ? ECOG performance status 0-2 ? life expectancy = 24weeks
Exclusion criteria
Exclusion criteria: ? Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin =800 ng/mL OR transferrin saturation =50%) ? If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.) ? Ongoing bleeding at the time of study registration ? Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia) ? Presence of bone marrow tumor invasion ? Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration ? History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration ? Past or family history of hemochromatosis ? History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ? Uncontrolled acute or chronic infection ? Renal dysfunction (serum creatinine =2.0 mg/dL, or glomerular filtration rate <30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal) ? Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Hb concentration from baseline to 12 weeks [end of treatment] | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Hemoglobin response: defined as an increase in Hb level of 2.0g/dL= from baseline value during 12-week study period ? Time to hemoglobin response ? Proportion of patients requiring RBC transfusion during 12-week study period ? Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L ? Safety analysis ? Medical economics analysis ? Observation of gene expression patterns after combination therapy in cancer cell lines (by quantitative RT-PCR) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Zang Dae
Hallym University Medical Center
Outcome results
None listed