Clinical trial · Interventional
Intravenous Iron Infusion on Chemotherapy-induced Anemia
Preventive Effect of Intravenous Iron Infusion on Chemotherapy-induced Anemia of Colon Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic-Induced Anemia | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dried Ferrous Sulfate | Drug | — | UNRESOLVED |
| iron (isomaltoside) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IVI
- description
- patients group with intravenous iron infusion
- interventionNames
- Drug: iron (isomaltoside)
- type
- ACTIVE_COMPARATOR
- label
- OI
- description
- patients group with oral iron supplement
- interventionNames
- Drug: Dried Ferrous Sulfate
Primary outcomes (1)
- measure
- Serum Hb level
- timeFrame
- during chemotherapy
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available