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Study on Reducing Post-Surgery Complications in Cancer Patients Using Ketorolac, Aspirin, and a Drug Combination

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What is this study about?

This clinical trial is focused on patients undergoing major surgery for cancer treatment. The study aims to explore the effects of a specific treatment plan on reducing complications after surgery. The treatment involves a combination of medications and dietary changes. Before surgery, patients will receive an injection of ketorolac, a medication used to reduce pain and inflammation. After surgery, patients will take low-dose aspirin, which is commonly used to prevent blood clots, along with following a special diet designed to manage blood sugar levels.

The purpose of the study is to see if this combination can help reduce serious health issues that might occur within 90 days after surgery. The study will involve monitoring patients’ health and recovery over a period of time to assess the effectiveness of the treatment. Participants will be given either the treatment or a placebo to compare the outcomes. The study will also use sodium chloride solution, commonly known as saline, for infusion as part of the standard care during surgery.

By participating in this study, researchers hope to find better ways to support patients with cancer who are undergoing major surgeries, aiming to improve their recovery and reduce the risk of complications. The study will continue for several years to gather comprehensive data on the long-term benefits of the treatment plan.

1 joining the trial

Upon joining the trial, you will be asked to provide written consent, confirming your understanding and willingness to participate.

You will undergo a series of assessments to ensure you meet the eligibility criteria, including age, organ function, and medical history.

2 preoperative phase

Before your surgery, you will receive a medication called ketorolac trometamol as a solution for injection. This is intended to help manage inflammation.

The specific dosage and frequency will be determined by the medical team based on your individual needs.

3 surgery

You will undergo the planned major surgery for your oncologic condition. The surgery is performed with the intent to cure.

4 postoperative phase

After your surgery, you will begin taking acetylsalicylic acid (commonly known as aspirin) in the form of gastro-resistant tablets. This is a low-dose medication aimed at reducing inflammation.

You will also follow a hypoglycemic diet, which is designed to help control blood sugar levels and further reduce inflammation.

5 follow-up and monitoring

You will be monitored for 90 days and up to 1 year after your surgery to assess your recovery and any potential complications.

Regular check-ups will be scheduled to evaluate your health status and the effectiveness of the treatment.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have adequate organ function, which means:
    • Enough white blood cells to fight infection (absolute neutrophil count ≥ 1,500/mm3).
    • Enough platelets to help blood clot (platelet count ≥ 100,000/mm3).
    • Enough red blood cells to carry oxygen (hemoglobin ≥ 9 g/dl).
    • Liver enzymes (AST and ALT) should not be more than 1.5 times the normal limit, unless there are liver metastases, in which case they can be up to 3 times the normal limit.
    • Bilirubin, a substance made by the liver, should not be more than 1.5 times the normal limit.
    • Kidneys should be working well enough to clear creatinine at a rate of ≥ 45 ml/min or have a serum creatinine level ≤ 1.5 times the normal limit.
  • Must be able to understand and willing to sign a written informed consent document.
  • Having used aspirin before or currently using it does not prevent participation.
  • Must have cancer confirmed by a tissue sample (histologically documented cancer).
  • Surgery must be planned with the goal of curing the cancer.
  • Must have a high RBT index (≥18), which is a measure used in the study.
  • Must be scheduled for major surgery, which includes surgeries on the chest, head and neck, abdomen, urinary and reproductive organs, and breast or reconstructive surgeries.
  • Must have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Female participants must not be pregnant or breastfeeding. Women who can have children must agree to use approved birth control during the study and for at least 120 days after the last dose of study treatment.
  • Must have controlled blood pressure, with or without medication, defined as blood pressure ≤ 150/90 mmHg at screening and no recent changes in blood pressure medication.

Who Cannot Join the Study?

  • Patients who are not scheduled for major surgery for cancer-related reasons cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

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

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
16.12.2024

Trial locations

Investigated drugs:

Ketorolac is a medication that helps reduce pain and inflammation. It is often used before surgery to help manage pain and reduce swelling. In this trial, ketorolac is given before surgery to help control inflammation, which might help improve recovery after the operation.

Aspirin is a common medication that is used to reduce pain, fever, and inflammation. In this trial, a low dose of aspirin is given after surgery. The goal is to help reduce inflammation and possibly lower the risk of complications after the surgery.

A hypoglycemic diet is a type of eating plan that focuses on keeping blood sugar levels low. This diet is part of the trial to see if it can help improve recovery after surgery by reducing inflammation and supporting overall health.

Oncologic Indication – This term refers to conditions related to cancer, where abnormal cells grow uncontrollably and may spread to other parts of the body. Cancer can originate in almost any organ or tissue, such as the lungs, colon, breast, skin, bones, or nerve tissue. The progression of cancer typically involves stages, starting from a localized tumor that may grow and invade nearby tissues. As the disease advances, cancer cells can break away and travel through the blood or lymphatic system to form new tumors in other organs, a process known as metastasis. The rate of progression and the specific symptoms experienced can vary widely depending on the type and location of the cancer. Cancer can affect bodily functions and may lead to various complications as it progresses.

Trial ID:
2024-515333-14-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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