Intravenous Iron Infusion on Chemotherapy-induced Anemia

NCT05299411 | Unknown Phase 2 DMC

• 1 other identifier: 2021GR0540
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer; Chemotherapeutic-Induced Anemia

Outcome Measures

Primary Outcomes (1)

• Serum Hb level

  during chemotherapy

Secondary Outcomes (1)

• Serum hepcidin level

  during chemotherapy

Other Outcomes (1)

• Quality of life associated anemia

  during chemotherapy

Study Arms (2)

IVI

EXPERIMENTAL

patients group with intravenous iron infusion

Drug: iron (isomaltoside)

OI

ACTIVE COMPARATOR

patients group with oral iron supplement

Drug: Dried Ferrous Sulfate

Interventions

iron (isomaltoside) DRUG

iron supplement through intravenous infusion

IVI

Dried Ferrous Sulfate DRUG

iron supplement through oral intake

OI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Pharmbio Korea Inc.: collaborator

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 29, 2022
• Study Start: April 20, 2023
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 29, 2022

Record last verified: 2022-03