Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer

NCT05220800 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: REG-180-2020
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

Brief Summary

This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel

Conditions

Iron-deficiency; Colorectal Cancer

Keywords

surgery; Iron-deficiency; Colorectal cancer; Intravenous iron

Outcome Measures

Primary Outcomes (3)

• Change in oxygen uptake at the anaerobic threshold

  Change in oxygen uptake at the anaerobic threshold measured by cardiopulmonary exercise test before infusion and the days before surgery

  at baseline and 1-4 days before surgery

• Change in neutrophile to lymphocyte ratio (NLR)

  Change in neutrophile to lymphocyte ratio (NLR) between baseline bloodwork and prior to surgery.

  at baseline and 1-4 days before surgery

• Changes in T-cell function - mRNA expression analysis

  Nanostring pancancer immune analysis of tumor samples

  1 day after surgery

Secondary Outcomes (5)

• Quality of Recovery 15 (QoR-15)

  Up to 7 days after surgery

• Complications

  30-days after surgery

• Days alive and out of hospital - 30

  30 days after surgery

• 1 year cancer free survival

  1 year after surgery

• 5 year cancer free survival

  5 years after surgery

Study Arms (2)

Iron(III)isomaltoside 1000

EXPERIMENTAL

Weight-dependent one-time dosage of intravenous administration of iron(III)isomaltoside given prior to surgery. Dosage: \<50 kg body weight = 500 mg, 50-59 kg body weight = 600 mg, 60-59 kg body weight = 700 mg, 70-79 kg body weight = 800 mg, 80-89 kg body weight = 900 mg, and 90+ kg body weight = 1000 mg.

Drug: Iron(III)isomaltoside

Placebo

PLACEBO COMPARATOR

500 ml isotonic saline infusion fluid

Drug: Placebo

Interventions

Iron(III)isomaltoside DRUG

Weight-dependent dosage of iron(III)isomaltoside. See group descriptions

Iron(III)isomaltoside 1000

Placebo DRUG

Isoton saline infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for curative intended elective colon or rectum cancer surgery
• UICC stage I-III (at diagnosis)
• Hemoglobin \> 7.0 mmol/L
• Serum ferritin \<101 microgram/L or transferrin saturation \<21%

You may not qualify if:

• Chronic kidney failure with need for dialysis
• Metachronous diagnosed cancer
• Unable to speak or understand Danish
• Cognitive impairment e.g. moderate to severe dementia
• Concurrent severe active bacterial infection
• Known allergy for Iron(III)isomaltoside
• Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)
• Withdrawal of informed consent
• Neoadjuvant chemo or radiation therapy
• Pregnancy

Sponsors & Collaborators

• Zealand University Hospital: lead
• Randers Regional Hospital: collaborator
• Slagelse Hospital: collaborator

Study Sites (3)

Zealand University Hospital

Køge, Danmark, 4600, Denmark

Location

Slagelse Hospital

Slagelse, Danmark, 4200, Denmark

Location

Regionshospitalet Randers

Randers, 8930, Denmark

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Rasmus Dahlin Bojesen, Ph.d., MD.

CONTACT

+4526193789; radb@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Concealement by opaque infusion bags and iv. drips.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded clinical randomized trial.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 3, 2022

Record last verified: 2022-01

Locations

DK (3)