NCT05220800Not yet recruitingPhase 2
Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer
Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer: A Double Blinded Clinical Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 21 Jan 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Zealand University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05220800
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 134
- From 1 Mar 2022 to the primary completion date, 1 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent severe active bacterial infection
- Neoadjuvant chemo or radiation therapy
Other illness
- Chronic kidney failure with need for dialysis
- Metachronous diagnosed cancer
- Cognitive impairment e.g. moderate to severe dementia
- Known allergy for Iron(III)isomaltoside
Lab values
- Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)
Other
- Unable to speak or understand Danish
- Withdrawal of informed consent
- Pregnancy
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zealand University Hospital Coordinator of this site? Confirm its status | Køge | Denmark | Unknown status |
| Regionshospitalet Randers Coordinator of this site? Confirm its status | Randers | Denmark | Unknown status |
| Slagelse Hospital Coordinator of this site? Confirm its status | Slagelse | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.