Intravenous Iron Infusion on Chemotherapy-induced Anemia

Study Overview
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Brief Summary
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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.

Official Title
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Preventive Effect of Intravenous Iron Infusion on Chemotherapy-induced Anemia of Colon Cancer Patients

Conditions
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Colon Cancer, Chemotherapeutic-Induced Anemia

Intervention / Treatment
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* Drug: iron (isomaltoside)
* Drug: Dried Ferrous Sulfate


Participation Criteria
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Eligibility Criteria
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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 more than 18 years old baseline Hb level <12g/dL or more Hb 2g/dL decrease after chemotherapy patients who received more than 1 cycle of FOLFOX6 Exclusion Criteria: * patients with neoadjuvant therapy patients who have other diseases associated with anemia such as CKD, IBD, other bone marrow diseases patients who received RBC transfusion during chemotherapy patients diagnosed with local recurrence or distant metastasis during chemotherapy ferritin > 800 ng/mL and TSAT ≧ 50% patients who are not willing to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVI<br>patients group with intravenous iron infusion | Drug: iron (isomaltoside)<br>* iron supplement through intravenous infusion<br>|
| Active Comparator: OI<br>patients group with oral iron supplement | Drug: Dried Ferrous Sulfate<br>* iron supplement through oral intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Hb level |  | during chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin level |  | during chemotherapy |