Study on Preoperative Iron Infusion with Ferric Carboxymaltose for Patients with Stomach Cancer

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What is this study about?

This clinical trial is focused on patients with gastric cancer, which is a type of cancer that affects the stomach. The study is investigating the use of a treatment called ferric carboxymaltose, which is a form of iron given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to see if giving this iron treatment before surgery can reduce the need for blood transfusions and lower the risk of complications after surgery for gastric cancer.

Participants in the study will receive the iron treatment before their surgery. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects. The study will monitor the number of patients who need blood transfusions, as well as their hemoglobin levels, which is a measure of the amount of oxygen-carrying protein in the blood, and any complications that occur after surgery. The study will also look at the quality of life of the participants after their surgery.

The trial is expected to continue for several years, allowing researchers to gather enough information to determine the effectiveness of the iron treatment in improving outcomes for patients with gastric cancer. The results of this study could help improve the care and recovery of patients undergoing surgery for this type of cancer.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This involves reviewing the medical history to ensure the presence of gastric cancer and that the patient is an adult.

No specific exclusion criteria are mentioned, so the focus is on confirming the inclusion criteria.

2 preoperative iron infusion

The main treatment involves the administration of ferric carboxymaltose through an intravenous infusion. This is a dispersion for injection or infusion.

The purpose of this step is to investigate if the iron infusion can decrease the risk of needing blood transfusions and reduce complications after surgery for gastric cancer.

3 sodium chloride infusion

Alongside the iron infusion, sodium chloride is administered as a solution for infusion. This is also done intravenously.

The sodium chloride solution is used to support the iron infusion process.

4 surgery and postoperative monitoring

After the preoperative treatments, the patient undergoes surgery for gastric cancer.

Postoperative monitoring includes checking the hemoglobin (Hb) level, observing for any complications, and assessing the patient’s quality of life.

5 evaluation of outcomes

The primary outcome measured is the number of patients who require blood transfusions.

Secondary outcomes include postoperative hemoglobin levels, any complications that arise, and the overall quality of life after the surgery.

Who Can Join the Study?

Must be an adult with gastric cancer. This means you have a type of cancer that affects the stomach.
Must be at least 18 years old.
Both men and women can participate.
Participants should not belong to a vulnerable population. This means you should not be in a group that needs special protection or care.

Who Cannot Join the Study?

Patients who do not have gastric cancer cannot participate. Gastric cancer is a type of cancer that affects the stomach.
Individuals who are not within the specified age range cannot participate. The age range for this study is not specified here, but it usually means there is a minimum and maximum age limit.
People who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hbjzoccu Uwsykygflz Czojrvu Hahjexyw	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.04.2020

Trial locations

Investigated drugs:

Intravenous Iron Therapy is used in this clinical trial to help patients with gastric cancer. The therapy involves giving iron directly into the bloodstream through a vein. This is done before surgery to see if it can reduce the need for blood transfusions and lower the risk of complications after the operation. The goal is to improve the patient’s health and recovery by ensuring they have enough iron in their body before undergoing surgery.

Investigated diseases:

Gastric cancer

Gastric Cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It often starts in the mucus-producing cells on the stomach’s inner surface, known as adenocarcinoma. As the disease progresses, it can invade deeper layers of the stomach wall and spread to nearby organs. Symptoms may include indigestion, stomach pain, nausea, and loss of appetite. Over time, the cancer can spread to lymph nodes and other parts of the body. The progression and symptoms can vary depending on the cancer’s location and stage.

Trial ID:

2024-519738-21-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preoperative Iron Infusion with Ferric Carboxymaltose for Patients with Stomach Cancer

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