Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Colorectal Cancer Clinical Trial

Official title:

Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05221957
• Other study ID #: REG-056-2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: Zealand University Hospital
• Contact: Rasmus D Bojesen, MD
• Phone: +4526193789
• Email: radb[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery.

The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside.

The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing curative intended surgery for colon or rectum cancer

• UICC stage I-III

Exclusion Criteria:

• Neoadjuvant oncological treatment

• Acute / subacute surgery

• Palliative surgery

• Other pathology than adenocarcinoma

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Colorectal Cancer
• Colorectal Neoplasms
• Iron-deficiency

Intervention

Drug:
• Iron(III)isomaltoside
Individual weight and hemoglobin dependent dosage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression and lymphocyte infiltration of the tumor	770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor	1 day after surgery
Primary	Complications	Postoperative complications after surgery measured by the Clavien-Dindo classification	30 days after surgery
Secondary	Length of stay	Length of postoperative hospital stay, until discharge or death.	up to 100 days
Secondary	Readmission	Any readmission over 24 hours in length	Within 30 days after surgery
Secondary	Time to chemotherapy	Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease	up to 100 days
Secondary	Perioperative blood transfusions	Any blood transfusions measured in ml.	from outpatient assesment to 30 days after surgery
Secondary	Mortality	Mortality	30 days, 90 days and one year