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| Name | Class |
|---|---|
| Pharmbio Korea Inc. | UNKNOWN |
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FOLFOX, the first-line regimen based on 5-FU and oxaliplatin, is adjuvant chemotherapy for pathologic stage II/III colorectal cancer patients. Among various side effects of FOLFOX, chemotherapy-induced anemia occurs in about 30% of patients with FOLFOX chemotherapy. An oral iron supplement is a widely accepted treatment for chemotherapy-induced anemia, but an oral iron supplement has a lot of inconveniences that can make patients' adherence worse, such as gastrointestinal discomfort, a long period of oral intake, and late recovery of serum iron level.
Intravenous iron infusion has been recently reported to be effective and safe to correct anemia. Previous studies reported that intravenous iron is also effective to correct chemotherapy-induced anemia. However, there is a paucity of studies associated with colorectal cancer patients with FOLFOX chemotherapy.
This study aimed to evaluate the effect of intravenous iron on chemotherapy-induced anemia after FOLFOX chemotherapy for patients with colorectal cancer compared with the effect of oral iron supplements. Parameters including serum Hb, serum iron, serum ferritin concentrations, total iron-binding capacity, absolute neutrophil count, platelet, albumin, C reactive protein, hepcidin, soluble transferrin receptor, and IL6 will be analyzed. In addition, information on chemotoxicity, adverse events during chemotherapy and quality of life will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVI | Experimental | patients group with intravenous iron infusion |
|
| OI | Active Comparator | patients group with oral iron supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron (isomaltoside) | Drug | iron supplement through intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Hb level | during chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Serum hepcidin level | during chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life associated anemia | FACT-An (Version 4) | during chemotherapy |
Inclusion Criteria:
* clinical diagnosis of stage II or III after curative resection for colon cancer and planned to be received modified FOLFOX6 as an adjuvant chemotherapy
Exclusion Criteria:
* patients with neoadjuvant therapy
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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| Dried Ferrous Sulfate |
| Drug |
iron supplement through oral intake |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |