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临床试验/NCT05299411
NCT05299411尚未招募2 期

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

Korea University Guro Hospital0 个研究点目标入组 80 人开始时间: 2023年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
80
主要终点
Serum Hb level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • * 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

排除标准

  • * 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

研究组 & 干预措施

OI

Active Comparator

patients group with oral iron supplement

干预措施: Dried Ferrous Sulfate (Drug)

IVI

Experimental

patients group with intravenous iron infusion

干预措施: iron (isomaltoside) (Drug)

结局指标

主要结局

Serum Hb level

时间窗: during chemotherapy

次要结局

  • Serum hepcidin level(during chemotherapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bong, Jun Woo

Clinical Associate Professor

Korea University Guro Hospital

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