Intravenous Iron Infusion on Chemotherapy-induced Anemia

March 18, 2022 updated by: Bong, Jun Woo, Korea University Guro Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Hb level
Time Frame: during chemotherapy
during chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum hepcidin level
Time Frame: during chemotherapy
during chemotherapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life associated anemia
Time Frame: during chemotherapy
FACT-An (Version 4)
during chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Pharmbio Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 20, 2023

Primary Completion (ANTICIPATED)

March 31, 2025

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (ACTUAL)

March 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021GR0540

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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