Intravenous Iron Infusion on Chemotherapy-induced Anemia

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299411
• Other study ID #: 2021GR0540
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2022
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• iron (isomaltoside)
iron supplement through intravenous infusion
• Dried Ferrous Sulfate
iron supplement through oral intake

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Pharmbio Korea Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life associated anemia	FACT-An (Version 4)	during chemotherapy
Primary	Serum Hb level		during chemotherapy
Secondary	Serum hepcidin level		during chemotherapy