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

1 1 1

What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	16.12.2025

Trial locations

Investigated drugs:

Acetylsalicylic Acid

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.

Investigated diseases:

Inflammation

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 ID:

2024-515333-14-03

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?