FERRIC DERISOMALTOSE for Colorectal cancer|Iron deficiency

Inclusion criteria

• {"criterion_text":"- Planned for curative intended elective colon or rectum cancer surgery"}
• {"criterion_text":"- UICC stage I-III"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- Hgb > 7.0 mmol/L for both men and women."}
• {"criterion_text":"- Serum ferritin ≤100 μg/L or Transferrin saturation (TSAT) ≤20 for both men and women."}

Exclusion criteria

• {"criterion_text":"- Chronic kidney failure, with need for dialysis"}
• {"criterion_text":"- Neoadjuvant chemo or radiation therapy"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Metachronous diagnosed cancer"}
• {"criterion_text":"- Unable to speak and understand Danish"}
• {"criterion_text":"- Cognitive impairment e.g. moderate to severe dementia"}
• {"criterion_text":"- Concurrent severe active bacterial infection"}
• {"criterion_text":"- Known allergy of monofer"}
• {"criterion_text":"- Contraindication for iv. iron infusion (Porfyria cutanea tarda, Livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)"}
• {"criterion_text":"- Treatment with iron infusion for other reasons"}
• {"criterion_text":"- Withdrawal of informed consent"}

Primary endpoints

• {"endpoint_text":"- Changes in cellular respiration (VO2max at the Anaerobic Threshold) measured by the gold standard Cardio Pulmonary Exercise Testing (CPET).","definition_or_measurement_approach":"Measured by Cardio Pulmonary Exercise Testing (CPET) assessing VO2max at the Anaerobic Threshold."}
• {"endpoint_text":"- The preoperative change in the Neutrophil to Lymphocyte Ratio (NLR)","definition_or_measurement_approach":"As written: preoperative change in NLR (measured from blood counts/laboratory testing as specified in trial documents)."}
• {"endpoint_text":"- The up and downregulation of immune function at the invasive front of the tumor, measured by the Nanostring™ PanCancer Immune® profiling panel","definition_or_measurement_approach":"Measured by the Nanostring™ PanCancer Immune® profiling panel on tumor tissue."}

Secondary endpoints

• {"endpoint_text":"- The patients subjective description of physical capacity measured by the Fatique Severity Score questionnaire","definition_or_measurement_approach":"Patient-reported physical capacity using the Fatique Severity Score questionnaire (as written)."}
• {"endpoint_text":"- Treatment characteristics such as: Adverse events, serious adverse events, 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 during the admission","definition_or_measurement_approach":"Assessed via clinical records, laboratory measurements (transferrin, ferritin, TSAT, iron, hemoglobin, phosphate), adverse event reporting, Comprehensive Complication Index and Quality of Recovery-15 (QoR-15) as written."}
• {"endpoint_text":"- One and five year survival rates and recurrence rates.","definition_or_measurement_approach":"Follow-up assessment of survival and recurrence at one and five years as written."}

Denmark

Latest Decision Or Authorization Date

15-11-2024

Number Of Sites

3

Number Of Participants

134

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}