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Intravenous Iron Infusion on Chemotherapy-induced Anemia

Primary Purpose

Colon Cancer, Chemotherapeutic-Induced Anemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
iron (isomaltoside)
Dried Ferrous Sulfate
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IVI

    OI

    Arm Description

    patients group with intravenous iron infusion

    patients group with oral iron supplement

    Outcomes

    Primary Outcome Measures

    Serum Hb level

    Secondary Outcome Measures

    Serum hepcidin level

    Full Information

    First Posted
    March 10, 2022
    Last Updated
    March 18, 2022
    Sponsor
    Korea University Guro Hospital
    Collaborators
    Pharmbio Korea Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05299411
    Brief Title
    Intravenous Iron Infusion on Chemotherapy-induced Anemia
    Official Title
    Preventive Effect of Intravenous Iron Infusion on Chemotherapy-induced Anemia of Colon Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 20, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Guro Hospital
    Collaborators
    Pharmbio Korea Inc.

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Cancer, Chemotherapeutic-Induced Anemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IVI
    Arm Type
    Experimental
    Arm Description
    patients group with intravenous iron infusion
    Arm Title
    OI
    Arm Type
    Active Comparator
    Arm Description
    patients group with oral iron supplement
    Intervention Type
    Drug
    Intervention Name(s)
    iron (isomaltoside)
    Intervention Description
    iron supplement through intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Dried Ferrous Sulfate
    Intervention Description
    iron supplement through oral intake
    Primary Outcome Measure Information:
    Title
    Serum Hb level
    Time Frame
    during chemotherapy
    Secondary Outcome Measure Information:
    Title
    Serum hepcidin level
    Time Frame
    during chemotherapy
    Other Pre-specified Outcome Measures:
    Title
    Quality of life associated anemia
    Description
    FACT-An (Version 4)
    Time Frame
    during chemotherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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