Study on the Effects of Intravenous Ferric Derisomaltose in Non-Anemic Iron Deficient Patients with Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying the effects of intravenous iron treatment in patients with colorectal cancer who have iron deficiency but are not anemic. The treatment being tested is called Monofer, which contains the active substance ferric derisomaltose. This study will compare the effects of Monofer with a placebo to understand how it impacts physical capacity and immune function in these patients.

The purpose of the study is to evaluate how the iron treatment affects the patients’ physical abilities and immune system, particularly looking at changes in the Neutrophil to Lymphocyte Ratio (NLR) and using a method called Nanostring to analyze immune responses. The study will also investigate the effects of the treatment on the tumor environment and the patients’ overall health outcomes, both in the short and long term.

Participants in the study will receive the treatment through an intravenous infusion, which means the solution is given directly into a vein. The study will monitor various health indicators, including physical capacity, immune function, and any side effects. The goal is to gather information that could help improve treatment strategies for patients with colorectal cancer who have iron deficiency.

1 joining the study

Upon joining the study, participation is confirmed for individuals with colorectal cancer who meet specific criteria, such as being planned for surgery and having certain iron levels.

2 initial assessment

An initial assessment is conducted to evaluate physical capacity and immune function. This includes measuring cellular respiration and immune markers.

3 medication administration

Participants receive an intravenous infusion of either iron or a placebo. The iron used is ferric derisomaltose, administered as a solution for injection or infusion.

4 monitoring and evaluation

Participants are monitored for changes in physical capacity and immune function. This includes tracking the Neutrophil to Lymphocyte Ratio and using advanced profiling methods to assess immune response.

5 follow-up assessments

Follow-up assessments are conducted to evaluate the effects of the treatment on physical capacity and immune function. Participants may complete questionnaires about their physical capacity and fatigue levels.

6 long-term outcomes

Long-term outcomes, such as survival rates and recurrence rates, are tracked over one and five years to assess the impact of the treatment.

Who Can Join the Study?

The patient must be scheduled for a planned surgery to remove cancer in the colon or rectum with the aim of curing the disease.
The cancer must be at UICC stage I-III, which means the cancer is in an early to moderately advanced stage.
The patient must be 18 years or older.
The patient’s hemoglobin (Hgb) level must be greater than 7.0 mmol/L. Hemoglobin is a protein in red blood cells that carries oxygen.
The patient’s serum ferritin level must be 100 micrograms per liter (μg/L) or less, or their Transferrin saturation (TSAT) must be 20% or less. Ferritin is a protein that stores iron, and transferrin saturation is a measure of how much iron is bound to a protein that carries it in the blood.

Who Cannot Join the Study?

Patients who do not have iron deficiency cannot participate. Iron deficiency means having lower than normal levels of iron in the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not diagnosed with colorectal cancer cannot participate. Colorectal cancer is a type of cancer that affects the colon or rectum.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection, such as children or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Slagelse Hospital	Slagelse	Denmark
Region Sjaelland	Holbæk	Denmark
Hlzxexmt Hlvqmceo	Hvidovre	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Iron is used in this clinical trial to help patients with colorectal cancer who have low iron levels but are not anemic. The iron is given through an infusion directly into the bloodstream. The goal is to see if this treatment can improve the physical capacity of these patients and to study any changes in their immune system. Researchers are also interested in understanding how this iron treatment might affect the cancer environment in the body over both short and long periods.

Investigated diseases:

Iron deficiency

Iron Deficiency – Iron deficiency is a condition where the body lacks enough iron to produce hemoglobin, the protein in red blood cells that carries oxygen. This can lead to symptoms such as fatigue, weakness, and pale skin. As the deficiency progresses, individuals may experience shortness of breath, dizziness, or cold hands and feet. It can result from inadequate dietary intake, increased iron needs, or loss of blood. Over time, iron deficiency can affect physical performance and cognitive function. It is important to address the underlying cause to prevent further complications.

Trial ID:

2024-518517-26-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Intravenous Ferric Derisomaltose in Non-Anemic Iron Deficient Patients with Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?