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Tittle: Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. A double blinded clinical randomized trial.
EU CTIS ID: 2024-518517-26-00
What this study is testing
Evaluation of physical capacity in patients with colorectal cancer after infusion of iron or placebo and to evaluate immunological changes in patients with colorectal cancer after infusion of iron/placebo using Neutrophil to lymphocyte ratio (NRL) and Nanostring methodology and thereby investigate the effects of intravenously administered iron on both short- and long term outcomes and effects on the tumor microenviroment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Planned for curative intended elective colon or rectum cancer surgery
- UICC stage I-III
- Age ≥ 18
- Hgb > 7.0 mmol/L for both men and women.
- Serum ferritin ≤100 μg/L or Transferrin saturation (TSAT) ≤20 for both men and women.
You likely can't join if
- Chronic kidney failure, with need for dialysis
- Neoadjuvant chemo or radiation therapy
- Pregnancy
- Metachronous diagnosed cancer
- Unable to speak and understand Danish
- Cognitive impairment e.g. moderate to severe dementia
See the full eligibility criteria
- Planned for curative intended elective colon or rectum cancer surgery
- UICC stage I-III
- Age ≥ 18
- Hgb > 7.0 mmol/L for both men and women.
- Serum ferritin ≤100 μg/L or Transferrin saturation (TSAT) ≤20 for both men and women.
- Chronic kidney failure, with need for dialysis
- Neoadjuvant chemo or radiation therapy
- Pregnancy
- Metachronous diagnosed cancer
- Unable to speak and understand Danish
- Cognitive impairment e.g. moderate to severe dementia
- Concurrent severe active bacterial infection
- Known allergy of monofer
- Contraindication for iv. iron infusion (Porfyria cutanea tarda, Livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)
- Treatment with iron infusion for other reasons
- Withdrawal of informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.