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Study on the Effects of Acetylsalicylic Acid and Cytisine for High-Risk Patients in Preventing Lung Cancer and Reducing Inflammation

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What is this trial about?

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

This clinical trial is focused on individuals at high risk of developing an inflammatory state and mortality from lung cancer, other cancers, and various causes. The study aims to evaluate the effectiveness of a multi-factor intervention in reducing inflammation. Participants will be given treatments that include Cardioaspirin (which contains acetylsalicylic acid) and Tabex (which contains cytisine). These medications are administered in the form of tablets taken orally.

The purpose of the study is to assess how these interventions can help reduce inflammation and improve overall health outcomes in high-risk individuals. The study will involve regular monitoring and assessments over a period of time to observe changes in health markers, such as inflammation levels and smoking habits. Participants will be randomly assigned to different groups, with some receiving the active medications and others receiving a placebo.

Throughout the study, participants will be encouraged to follow a healthy lifestyle, including adherence to the Mediterranean Diet and increased physical activity. The study will also track various health indicators, such as weight, waist circumference, and blood markers, to evaluate the overall impact of the interventions. The ultimate goal is to determine if these treatments can lead to a reduction in the incidence of lung cancer and improve the quality of life for those at high risk.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are required to sign an informed consent form. This form confirms understanding of the study and agreement to participate, including the processing of personal data.

  2. Step 2

    Initial assessment

    Participants undergo an initial assessment to confirm eligibility. This includes verifying age between 55 and 75 years, history of heavy smoking, and eligibility for annual chest CT screening. Participants must also demonstrate the ability to use the internet via a PC, tablet, or smartphone.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either acetylsalicylic acid or cytisine. Acetylsalicylic acid is administered as a 100 mg gastro-resistant tablet, taken orally. Cytisine is administered as a 1.5 mg film-coated tablet, also taken orally. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Throughout the study, participants attend regular follow-up assessments. These assessments monitor health status, adherence to the medication regimen, and any side effects experienced. Participants are also evaluated for changes in smoking habits, diet, physical activity, and overall quality of life.

  5. Step 5

    Final evaluation

    At the end of the study period, participants undergo a final evaluation. This includes measuring inflammatory markers, smoking cessation rates, adherence to the Mediterranean diet, physical activity levels, and any changes in weight or cardio-metabolic markers. The study aims to assess the overall impact of the interventions on health outcomes.

Who can join the trial?

7 criteria

  • Age between 55 and 75 years
  • Heavy smoker (someone who smokes a lot of cigarettes)
  • Eligible for screening with an annual chest CT (a special type of X-ray that takes detailed pictures of the lungs)
  • Availability and ability to use the Internet via PC, tablet, or smartphone
  • Ability to understand the project you want to participate in
  • No tumors in the last 5 years
  • Signature of informed consent (agreement to participate after understanding the study) for enrollment in the study and for the processing of personal data

Who cannot join the trial?

1 criterion

  • People who are at high risk of having an inflammatory state or dying from lung cancer, other cancers, or any cause cannot participate.
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Investigated drugs

I'm sorry, but the provided data does not include specific information about the medications or therapies involved in the clinical trial. If you have more detailed information or another source that lists the medications or therapies, please provide it so I can assist you further.

What is already known about the treatment

Multi-factorial Primary Prevention Intervention – This intervention is administered as a comprehensive program rather than a single medication, focusing on individuals at high risk of inflammation and mortality from lung cancer, other cancers, and all causes. Currently, this approach is being studied in clinical trials to assess its effectiveness in reducing inflammation and associated risks. The main therapeutic goal is to prevent the onset of severe inflammatory conditions and related diseases. The intervention works by addressing multiple factors that contribute to inflammation, potentially including lifestyle changes, dietary adjustments, and other preventive measures. It is classified under preventive health strategies rather than traditional pharmacological categories.

Investigated diseases

  • Lung Cancer

    Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung's ability to provide oxygen to the bloodstream. The disease can spread to other parts of the body through the lymphatic system or bloodstream. Lung cancer is often associated with smoking, but it can also occur in non-smokers. Over time, the disease can lead to significant respiratory issues and other systemic complications.

  • Inflammatory State

    An inflammatory state refers to a condition where the body's immune system is persistently activated, leading to chronic inflammation. This can occur due to various factors, including infections, autoimmune disorders, or prolonged exposure to irritants. Chronic inflammation can cause damage to tissues and organs over time. It is often marked by elevated levels of certain biomarkers, such as C-reactive protein (CRP), in the blood. This state can contribute to the development of other diseases, such as cardiovascular diseases and certain types of cancer. Managing inflammation is crucial to prevent further health complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513660-26-00Protocol codeSMILEEstimated enrolment2 000 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).