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AuthorisedTherapeutic exploratory (Phase II)Interventional

Targeting inflammation to reduce 90-day and 1-year postoperative severe morbidity in patients with unfavorable inflammatory profile undergoing oncologic surgery (POST CARE Trial)

This study, called the POST CARE Trial, is for people who are about to have major surgery for cancer. We know that sometimes, after big operations, people can face serious problems like infections or other complications. This study is looking at whether giving certain medicines, specifically low-dose aspirin and another pain relief medication, can help prevent these serious issues from happening within 90 days and up to a year after surgery. The aim is to see if these treatments can make recovery smoother, particularly for patients who might have a higher risk of inflammation, which can affect healing. It's a Phase II trial, meaning doctors are testing if the treatments work and are safe.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Fondazione IRCCS Istituto Nazionale Dei Tumori
Enrolment target
83
Start
17 Dec 2025

What is this study about?

When you have a big operation for cancer, your body goes through a lot. Sometimes, this can lead to inflammation, which is your body's natural response to injury. While some inflammation is normal, too much can slow down healing and sometimes lead to serious problems like infections or other complications after surgery. These problems can make your recovery harder and longer.

This study, called the POST CARE Trial, is designed to find ways to make your recovery from cancer surgery as smooth and safe as possible. We are looking at whether certain existing medicines, low-dose aspirin and a pain relief injection, can help reduce the chances of these serious problems occurring. The idea is that these medicines might help control the inflammation that can lead to complications, especially if your body's natural inflammatory response is already a bit high.

By carefully studying how these medicines work in patients having cancer surgery, we hope to find better ways to support your recovery. This could mean fewer complications and a quicker return to good health after your operation. Your valuable contribution by taking part could help improve care for many future patients.

Key takeaways

  • Study aims to reduce serious problems after cancer surgery.
  • Investigates low-dose aspirin and a pain relief injection.
  • Focuses on patients who might have higher inflammation.
  • Participation involves monitoring for up to one year post-surgery.
  • This is a Phase II trial, testing safety and effectiveness.
  • Participation is voluntary and can be stopped any time.

Who may be eligible?

To be able to take part in this study, you must be an adult, aged 18 years or older, with no upper age limit. Both men and women can participate. The main requirement is that you are scheduled to have a major operation because of cancer.

Beyond these basic points, the researchers will check your individual health and medical history to make sure the study is a safe and suitable option for you. This will involve looking at your overall health to determine if you are a good fit for the study treatments and procedures.

There might be other specific health conditions or medications that would prevent you from taking part, but the study team will discuss all of these details with you thoroughly. Your doctor involved in the study will ensure it's right for your situation.

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.

  1. Are you 18 years old or older?
  2. Are you scheduled for major surgery for cancer?
  3. Are you able to speak with the study team and understand the information?
  4. Are you willing to attend follow-up appointments for up to a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given one of the study medicines – a low-dose aspirin tablet or another pain relief injection – around the time of your cancer surgery. The study team will explain exactly when and how often you'll take these.

The research team will closely monitor your health before, during, and after your surgery. This will include regular check-ups, potentially some blood tests, and discussions about how you're feeling. They will be looking out for any serious problems that might happen after your operation.

Your participation will involve follow-up appointments and communication with the study team for up to one year after your surgery. This is to understand the long-term effects of the treatments. The total duration of your participation will be explained in detail by the study staff.

Potential risks and benefits

Taking part in this study may offer a potential benefit by possibly reducing your risk of serious problems after cancer surgery, helping you recover more smoothly. However, like all medicines and treatments, there can be potential risks, including side effects from the medications. The doctors will carefully monitor you for any issues and are there to help if they arise. Your safety and well-being are the top priority. Please remember that participating is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What kind of cancer surgery is this for?

This study is for people scheduled to have major surgery for different types of cancer.

What medicines are being tested?

The study is testing a low-dose aspirin tablet and another pain relief medication given as an injection.

What does 'unfavorable inflammatory profile' mean?

It means the study is particularly interested in patients who might have higher levels of inflammation, which doctors can sometimes tell from certain tests, suggesting they could be at higher risk of complications after surgery.

Is this a new medicine never used before?

No, the medicines being tested (aspirin and the pain relief injection) are commonly used, but this study is looking at using them in a specific way to prevent problems after cancer surgery.

Will I definitely get the active treatment?

As this is a clinical trial, you might receive the study medicines or you might receive a placebo (a dummy treatment without active medicine) or standard care, or a combination. The research team will be able to explain this properly.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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