Iron-deficiency in colorectal cancer MedDRA version: 20.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 1
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer
Product Code: B03AC
Pharmaceutical Form: Infusion
INN or Proposed INN: Ferric derisomaltose
CAS Number: 9004-66-04
Current Sponsor code: Iron oligosaccharide
Sponsors
Centre for Surgical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Planned for curative intended elective colon or rectum cancer surgery - UICC stage I-III - Age = 18 - Hgb > 7.0 for both men and women - Serum ferritin =100 µg/L for both men and women Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 67 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 67
Exclusion criteria
Exclusion criteria: - Chronic kidney failure, with need for dialysis - Metachronous diagnosed cancer - Unable to speak and understand Danish - Cognitive impairment e.g. moderate to severe dementia - Severe active infection - Known allergy of monofer - Contraindication for iv. iron infusion - Withdrawal of informed consent - Neoadjuvant chemo or radiation therapy - Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is 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. ;Secondary Objective: The aim is 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. ;Primary end point(s): The study will have three separate primary outcomes. The first primary outcome will be changes in cellular respiration (VO2max at the Anaerobic Threshold) measured by the gold standard Cardio Pulmonary Exercise Testing (CPET). The second primary outcome is the preoperative change in the Neutrophil to Lymphocyte Ratio (NLR)30. The third outcome will be difference in up and downregulation of immune function at the invasive front of the tumor, measured by the Nanostring™ PanCancer Immune® profiling panel. ;Timepoint(s) of evaluation of this end point: Changes in cellular respiration and NLR measured between baseline and the day prior to surgery. Up and downregulation of immune function measured at the day of the surgery from resection specimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AE's, SAE´s , blood transfusions, changes in transferrin, ferritin, transferrin saturation, iron, hemoglobin and phosphate. Length of stay, infectious complications measured by the comprehensive complication index and quality of recovery-15. One and five years survival rates and recurrence rates. ;Timepoint(s) of evaluation of this end point: blood transfusions, changes in transferrin, ferritin, transferrin saturation, iron, hemoglobin and phosphate. Length of stay, infectious complications measured by the comprehensive complication index and quality of recovery-15. Will all be measured day 30 after surgery. One and five years survival rates and recurrence rates will be measured at year 1 and 5. AE's and SAE's will be measured within 48 hours after infusion | — |
Countries
Denmark
Contacts
Public ContactRasmus Dahlin Bojesen
Centre for Surgical Science
Outcome results
None listed