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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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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	Recruiting	15.07.2019

Trial locations

Investigated drugs:

Acetylsalicylic Acid

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.

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 ID:

2024-513660-26-00

Protocol code:

SMILE

NCT ID:

NCT00000000

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?