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Iron deficiency anemia is a common complication in patients who underwent gastrectomy and leads to a deterioration in patient's quality of life. Therefore iron supplementation is one of the important treatments in postgastrectomy patients.
Taking an oral iron is an option for iron supplementation, but the postgastrectomy patients has poor absorption of iron due to their anatomic change. Accordingly, intravenous iron supplementation has been emerged as another treatment option, but there are only a few studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron in patients underwent gastrectomy.
Therefore, this study aims to evaluate the iron supplementation method as intravenous injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy anemia.
Gastric cancer patients who underwent curative gastrectomy more than 1 year ago and hemoglobin level lower than 11 g/dL will be included in this trial. After the registration, the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n = 179).
Calculated dose of iron isomaltoside using Ganzoni formula will be injected intravenously in intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral iron group. Hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of life score at baseline and weeks 12 period will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV iron (Monofer) group | Experimental | Iron isomaltoside(Monofer) will be injected intravenously and injection dose will be calculated using Ganzoni formula. |
|
| Oral iron group | Active Comparator | Ferrous sulfate(Feroba-YOU) 160mg/day for 12 weeks will be taken per oral. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron isomaltoside (Monofer) intravenous infusion | Drug | The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (< 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg. If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Hemoglobin at 2,4,8 and 12 weeks | at Baseline and weeks 2, 4, 8, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| serum iron | at Baseline and weeks 2, 4, 8, and 12 | |
| serum ferritin | at Baseline and weeks 2, 4, 8, and 12 | |
| serum transferrin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Yonsei University College of Medicine, Seoul, Korea | Seoul | 120-752 | South Korea |
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|
| Ferrous sulfate(Feroba-YOU) per oral | Drug | 160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks. |
|
| at Baseline and weeks 2, 4, 8, and 12 |
| transferrin saturation | at Baseline and weeks 2, 4, 8, and 12 |
| QOL (quality of life) of the patients | at Baseline and weeks 2, 4, 8, and 12 |
| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
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