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

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05221957
• Collaborator: (none)
• Enrollment: 200
• Arms: 3
• Anticipated Duration (Months): 21

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Anemia; Iron-deficiency	Drug: Iron(III)isomaltoside	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Propensity score matched cohort studyPropensity score matched cohort study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iron(III)isomaltoside 1000 Anemic patients receiving treatment with iron(III)isomaltoside	Drug: Iron(III)isomaltoside; Individual weight and hemoglobin dependent dosage
No Intervention: Historical comparison Anemic patients without receiving treatment prior to surgery. Historical comparison.
No Intervention: Concurrent comparison Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery

Outcome Measures

Primary Outcome Measures

1. Gene expression and lymphocyte infiltration of the tumor [1 day after surgery]

   770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor

2. Complications [30 days after surgery]

   Postoperative complications after surgery measured by the Clavien-Dindo classification

Secondary Outcome Measures

1. Length of stay [up to 100 days]

   Length of postoperative hospital stay, until discharge or death.

2. Readmission [Within 30 days after surgery]

   Any readmission over 24 hours in length

3. Time to chemotherapy [up to 100 days]

   Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease

4. Perioperative blood transfusions [from outpatient assesment to 30 days after surgery]

   Any blood transfusions measured in ml.

5. Mortality [30 days, 90 days and one year]

   Mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zealand University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT05221957
• Other Study ID Numbers: REG-056-2020
• First Posted: Feb 3, 2022
• Last Update Posted: Feb 3, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zealand University Hospital: Anemia; Iron-deficiency anemia
• Additional relevant MeSH terms: Colorectal Neoplasms; Anemia; Anemia, Iron-Deficiency

Study Results

No Results Posted as of Feb 3, 2022