Intravenous Iron Infusion on Chemotherapy-induced Anemia

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05299411
Collaborator
Pharmbio Korea Inc. (Other)
80
2
32.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: iron (isomaltoside)
  • Drug: Dried Ferrous Sulfate
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Preventive Effect of Intravenous Iron Infusion on Chemotherapy-induced Anemia of Colon Cancer Patients
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: IVI

patients group with intravenous iron infusion

Drug: iron (isomaltoside)
iron supplement through intravenous infusion

Active Comparator: OI

patients group with oral iron supplement

Drug: Dried Ferrous Sulfate
iron supplement through oral intake

Outcome Measures

Primary Outcome Measures

  1. Serum Hb level [during chemotherapy]

Secondary Outcome Measures

  1. Serum hepcidin level [during chemotherapy]

Other Outcome Measures

  1. Quality of life associated anemia [during chemotherapy]

    FACT-An (Version 4)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Korea University Guro Hospital
  • Pharmbio Korea Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bong, Jun Woo, Clinical Associate Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT05299411
Other Study ID Numbers:
  • 2021GR0540
First Posted:
Mar 29, 2022
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022