Phase 2 Trial: Cytisine and ASA for Inflammation in Lifelong Smokers

Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2 Condition(s): Inflammation, Smoking Cessation, Diet Modification, Physical Activity, Lung Cancer Intervention(s): Cytisine (DRUG), Acetylsalicylic acid (DRUG), Diet Modification and Physical Activity Increase (OTHER), early lung cancer detection (DIAGNOSTIC_TEST), spirometry with CO test (DIAGNOSTIC_TEST) 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). Detailed: The most recent population-based studies carried out in Europe and the US on hundreds of thousands of individuals have unequivocally identified three principal causes of mortality, morbidity and chronic disability: tobacco smoke, inadequate diet, and reduced physical activity. These risk factors are in large part reversible, because in heavy smokers, even after 60 years of age, cessation is associated with a clear reduction in all-cause mortality. The finding that lifestyle and eating habits are associated with the development of cancer has been confirmed in many studies: smoking, a sedentary lifestyle, excess red meat, processed foods and sugars are associated with increased risk, while an active lifestyle, non-exposure to smoke (both active and passive), consumption of whole grains, legu Primary Outcome(s): Change in chronic inflammatory status Enrollment: 2000 (ESTIMATED) Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Start: 2019-07-23 | Primary Completion: 2024-12-31