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Clinical Trials in Italy / NCT03654105
Active, not recruiting Phase 2

Screening and Multiple Intervention on Lung Epidemics

NCT03654105 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase
Phase 2
Started
2019-07-23
Last updated
2026-03-27

Condition(s) studied

InflammationSmoking CessationDiet ModificationPhysical ActivityLung Cancer

Investigational drug(s) / intervention(s)

Cytisine →Acetylsalicylic acid →Diet Modification and Physical Activity Increaseearly lung cancer detectionspirometry with CO testanthropometic data collectionblood test

Cytisine: Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days). Subjects will be educated on how to take the product and informed about possible adverse effects.

Acetylsalicylic acid: The treatment will consist of Acetylsalicylic acid at 100mg once a day

Diet Modification and Physical Activity Increase: It will be proposed: 1. an optimal diet with the aim of favoring control of weight, abdominal fat and adequate nutritional status without increasing the levels of IGF-I and inflammatory factors or glycemic peaks, with periodic verification of the results 2. a regular and sustainable physical activity program with periodic verification of the results.

early lung cancer detection: standard treatment for early lung cancer detection with ultra low dose CT

spirometry with CO test: spirometry with CO test

anthropometic data collection: anthropometic data collection

blood test: blood test to assess the metabolic and inflammatory profile

Study summary

This prospective randomized pilot trial will evaluate a multiple intervention program of prevention in lifelong smokers aiming at reduction of chronic inflammation status through treatment with low-dose acetylsalicylic acid (ASA), smoking cessation with cytisine, targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).

Eligibility

Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age between 55 and 75 years * High consumption of cigarettes (≥ 30 packs/year) * Elegibility to annual LDCT screening * Confidence in Internet use * Absence of tumors for at least 5 years * Signed informed consent form Exclusion Criteria: * Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch, coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate) * Chronic treatment with acetylsalicylic acid, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol) * Treatment with methotrexate * Existing Mastocytosis * History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs * Gastroduodenal ulcer * Hemorrhagic diathesis * Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency) * Serious psychiatric problems * Previous treatment with Cytisine * Abuse of alcohol or other substances (even previous)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03654105 on ClinicalTrials.gov ↗ ← All trials in Italy