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Testing acetylsalicylic acid and ketorolac to reduce complications after cancer surgery in patients with high inflammation levels

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients who are scheduled for major surgery to remove cancer. The surgery can involve different parts of the body including the chest, head and neck, abdomen, urinary and reproductive organs, or breast with reconstructive procedures. The study will use two medications: acetylsalicylic acid, which is given as gastro-resistant tablets taken by mouth, and ketorolac trometamol, which is given as an injection solution. These medications work to reduce inflammation in the body.

The purpose of the study is to test whether the experimental treatment is effective and safe in reducing severe health problems that can occur after surgery. The study focuses on patients who have an unfavorable inflammatory profile, meaning their body shows signs of higher inflammation levels before surgery. The treatment aims to target this inflammation to help prevent complications that might develop within 90 days and up to one year after the operation.

Patients in the study will receive acetylsalicylic acid at a dose of 100 mg daily for up to 11 months and ketorolac trometamol at a dose of 30 mg/ml for one day. The study will monitor how well the treatment works and whether it causes any unwanted effects. Participants must have confirmed cancer diagnosis, be scheduled for surgery intended to cure the cancer, and have certain blood test results showing adequate organ function. The study will track patients' recovery and any health problems that may occur following their cancer surgery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and confirmation

    Your eligibility for the study will be confirmed based on specific criteria. This includes being at least 18 years old and having a confirmed cancer diagnosis through tissue examination.

    Your blood pressure will be checked to ensure it is adequately controlled, defined as readings at or below 150/90 mmHg.

    Blood tests will be performed to verify that your organs are functioning properly. This includes checking your white blood cell count (at least 1,500 per cubic millimeter), platelet count (at least 100,000 per cubic millimeter), and hemoglobin level (at least 9 grams per deciliter).

    Liver function will be assessed by measuring AST and ALT (enzymes that indicate liver health), which should be no more than 1.5 times the normal upper limit, and bilirubin (a substance processed by the liver), which should also be no more than 1.5 times the normal upper limit. If cancer has spread to your liver, these values may be up to 3 times the normal upper limit.

    Kidney function will be evaluated by measuring your creatinine clearance (a measure of how well your kidneys filter waste), which should be at least 45 milliliters per minute, or your serum creatinine (a waste product in the blood), which should be no more than 1.5 times the normal upper limit.

    Your overall physical condition will be assessed using the ECOG performance status scale, which measures your ability to carry out daily activities. Your score should be 0 or 1, meaning you are fully active or have some restrictions but can perform light work.

    An RBT index (a measure of inflammation in your body) will be calculated, and it must be 18 or higher for you to participate.

    If you are a woman of childbearing age, you must not be pregnant or breastfeeding, and you must agree to use approved methods of birth control during the treatment period and for at least 120 days after receiving the last dose of study treatment.

  2. Step 2

    Surgery

    You will undergo major surgery to remove cancer. The surgery is performed with the goal of curing your cancer.

    The type of surgery will depend on the location of your cancer and may involve the chest, head and neck, abdomen, urogenital area, or breast with reconstructive procedures.

    Major surgery is defined based on how extensive and complex the procedure is, its effects on your body's normal functions, and the expected recovery outcomes.

  3. Step 3

    Treatment with study medications

    After surgery, you will receive treatment with study medications designed to reduce inflammation in your body.

    The medications used in this study are acetylsalicylic acid (commonly known as aspirin) and ketorolac trometamol (a pain reliever and anti-inflammatory drug).

    Acetylsalicylic acid will be given as a tablet that is designed to pass through your stomach without dissolving and will dissolve in your intestines instead. The dose is 100 milligrams, and it will be taken by mouth.

    Ketorolac trometamol will be given as an injection into your muscle or vein. The concentration is 30 milligrams per milliliter.

    The specific dosage, frequency, and duration of these medications will be determined according to the study protocol, but these details are not specified in the available information.

  4. Step 4

    Follow-up assessments

    You will be monitored for complications and side effects during the study period.

    The study will assess your recovery and any serious health problems that occur within 90 days after surgery.

    Additional assessments will continue up to one year after your surgery to evaluate long-term outcomes.

    The overall study is expected to continue until December 2031, with patient enrollment beginning in December 2025.

Who can join the trial?

10 criteria

  • You must be 18 years of age or older
  • You must have cancer confirmed by tissue examination under a microscope
  • You must be scheduled for major surgery intended to remove the cancer completely. Major surgery includes operations on the chest, head and neck, abdomen, urinary and reproductive organs, or breast with reconstruction
  • You must have a high RBT index, which is a score of 18 or higher. This is a measure used to assess certain characteristics related to blood clotting
  • Your organs must work well enough, shown by blood tests including: white blood cells called neutrophils at least 1,500 per cubic millimeter, platelets which help blood clot at least 100,000 per cubic millimeter, hemoglobin which carries oxygen in your blood at least 9 grams per deciliter, liver enzymes called AST and ALT no more than 1.5 times the normal upper limit, bilirubin which is a substance processed by the liver no more than 1.5 times the normal upper limit, and kidney function shown by creatinine clearance at least 45 milliliters per minute or serum creatinine no more than 1.5 times the normal upper limit. If cancer has spread to your liver, liver enzymes may be up to 3 times the normal upper limit
  • Your blood pressure must be adequately controlled, meaning it should be 150/90 millimeters of mercury or lower, with or without blood pressure medications, and your blood pressure medications should not have changed recently
  • Your physical condition must be good, rated as 0 or 1 on the ECOG scale. This means you are fully active or able to do light work but not strenuous physical activity
  • You must be able to understand the study and willing to sign a consent form
  • If you are a woman who can become pregnant, you must not be pregnant or breastfeeding, and you must agree to use approved birth control methods during treatment and for at least 120 days after the last dose
  • Previous use of aspirin, a blood-thinning medication, does not prevent you from joining the study

Who cannot join the trial?

13 criteria

  • You have an active infection, which means you currently have an infection that your body is fighting
  • You have problems with your immune system, the part of your body that fights diseases and infections
  • You are taking medicines called immunosuppressants, which are drugs that weaken your immune system
  • You have severe heart disease, meaning serious problems with how your heart works
  • You have severe lung disease, meaning serious problems with how your lungs work
  • You have severe kidney disease, meaning serious problems with how your kidneys work
  • You have severe liver disease, meaning serious problems with how your liver works
  • You are pregnant or breastfeeding
  • You are not using effective birth control methods to prevent pregnancy if you are able to have children
  • You have had another type of cancer in the past 5 years, except for certain skin cancers that were successfully treated
  • You have a known allergy or bad reaction to the study treatment or similar medicines
  • You are participating in another clinical trial at the same time
  • You have a condition that makes it difficult for you to understand the study or follow the study rules
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Investigated drugs

Unfortunately, the clinical trial data provided does not contain specific information about the medications or therapies being tested in this study. The trial is focused on targeting inflammation to reduce complications after cancer surgery in patients with unfavorable inflammatory profiles, but the specific medications or treatments being used are not listed in the available information.

What is already known about the treatment

POST CARE Trial Experimental Treatment – This is an investigational anti-inflammatory therapy currently being studied in clinical trials for patients undergoing major cancer surgery. The treatment is designed to reduce severe complications that can occur within 90 days to one year after the operation by targeting the body's inflammatory response. The exact mechanism works at the cellular level to control inflammation that often develops in patients with unfavorable inflammatory profiles who are having oncologic procedures. This experimental medication is being evaluated both for how well it works in preventing post-surgical complications and for its overall safety in cancer surgery patients.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can form masses called tumors, which may invade nearby tissues and organs. Cancer can develop in almost any part of the body and may spread to distant areas through the blood or lymphatic system. The disease progresses when normal cells undergo genetic changes that cause them to multiply without the usual controls. As cancer advances, it can interfere with normal body functions and affect multiple organ systems. Different types of cancer behave differently and progress at varying rates depending on their location and characteristics.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515333-14-03Estimated enrolment83 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

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