AuthorisedTherapeutic use (Phase IV)Interventional

Preoperative intravenous iron therapy in patients with gastric cancer

This research is looking into how giving iron directly into a vein (an 'intravenous' iron drip) before surgery for stomach cancer might help patients. The main goal is to see if this treatment can lower the number of people who need blood transfusions during or after their operation. Researchers will also be checking iron levels after surgery, looking at any problems that come up, and understanding how the treatment affects patients' quality of life. This is a real-world study using already approved treatments to see how they work in everyday medical care for adults having stomach cancer surgery.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

202

Start

16 Dec 2024

Patients with gastric cancer

What is this study about?

This study is particularly for people who are having surgery for stomach cancer. We know that surgery and cancer itself can sometimes lead to patients becoming anaemic, which means they have lower levels of red blood cells or iron. When this happens, doctors might give a blood transfusion to help them recover. This research wants to find out if giving iron through a drip into a vein before the stomach cancer operation can reduce the need for these blood transfusions.

The main thing the doctors will be looking at is how many patients need a blood transfusion. But they're also interested in other important things. For example, they'll check iron levels after the surgery to see if the treatment helps keep them healthy. They will also keep an eye on any complications that might happen after surgery and, very importantly, they'll be asking patients about their quality of life – how they feel and how well they're managing day-to-day activities.

This is a 'Phase IV' study. This means the treatments being used (the iron drip and salt water drip) are already approved medicines. Doctors are using them in a new way or looking at them in a real-world setting to understand their benefits better for patients having stomach cancer surgery. The aim is to help improve recovery and make the surgical process smoother for patients.

Key takeaways

Study looks at iron drips before stomach cancer surgery.
Aims to reduce the need for blood transfusions.
Also checks recovery, complications, and quality of life.
Open to adults aged 18 and over with stomach cancer.
Uses approved iron medication.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to both men and women.

To be considered for this study, you need to be an adult, aged 18 or over. There is no upper age limit, meaning older adults are also welcome to take part.

You must have been diagnosed with stomach cancer and be preparing to have surgery for it.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have stomach cancer?
Are you scheduled for surgery for your stomach cancer?
Are you comfortable with receiving medication through a drip?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive iron medication through a drip into your vein before your planned stomach cancer surgery. This treatment is called Ferinject. Some participants might receive a salt-water drip instead, for comparison, though this study's description focuses on the iron. The specific number of visits and the full duration of your participation will be discussed with you by the study team, but it will generally involve medical assessments before and after your surgery to check your iron levels, how you're feeling, and to monitor your recovery. You will also be asked questions about your quality of life at different points.

Potential risks and benefits

Potential benefits of taking part could include better iron levels before surgery, which might lead to a quicker recovery and potentially reduce the need for blood transfusions. As with any medical treatment, there are potential risks, though these are usually small with intravenous iron – common side effects can include temporary changes at the injection site or feeling light-headed. More serious side effects are rare. All treatments carry some risk, and the study team will explain these fully. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is intravenous iron?

It means getting iron through a drip directly into a vein, rather than taking tablets.

Why is iron important for surgery?

Good iron levels help your body make healthy red blood cells, which are important for recovery and avoiding the need for blood transfusions.

What is a 'quality of life' assessment?

These are questions that help doctors understand how your treatment and recovery are affecting your well-being, daily activities, and general happiness.

Will I definitely get the iron treatment?

The study description focuses on the iron treatment. The study team will explain exactly what treatment you would receive if you take part.

Is this a new medicine?

No, the iron treatment (Ferinject) is already approved and used by doctors. This study is looking at how it helps specifically for stomach cancer surgery.