E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron-deficiency in colorectal cancer |
Jernmangel ved kolorektal cancer |
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E.1.1.1 | Medical condition in easily understood language |
Iron-deficiency in colorectal cancer |
Jernmangel ved kolorektal cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | Colon cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038038 |
E.1.2 | Term | Rectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022970 |
E.1.2 | Term | Iron deficiency |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | 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.
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E.5.2 | 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. |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is five years after the surgery of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |