Clinical trial · Interventional
Screening and Multiple Intervention on Lung Epidemics
Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial
NCT03654105CI-TRIAL-00106512SMILEactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diet Modification | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Physical Activity | — | UNRESOLVED | — |
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetylsalicylic acid | Drug | Aspirin | ALIAS |
| anthropometic data collection | Other | — | UNRESOLVED |
| blood test | Other | — | UNRESOLVED |
| Cytisine | Drug | — | UNRESOLVED |
| Diet Modification and Physical Activity Increase | Other | — | UNRESOLVED |
| early lung cancer detection | Diagnostic Test | — | UNRESOLVED |
| spirometry with CO test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Smoking cessation and Antinflammatory
- description
- Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
- interventionNames
- Drug: Cytisine
- Drug: Acetylsalicylic acid
- Other: Diet Modification and Physical Activity Increase
- Diagnostic Test: early lung cancer detection
- Diagnostic Test: spirometry with CO test
- Other: anthropometic data collection
- Other: blood test
- type
- EXPERIMENTAL
- label
- Smoking cessation
- description
- Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (37)
- BACKGROUNDPastorino U, Boffi R, Marchiano A, Sestini S, Munarini E, Calareso G, Boeri M, Pelosi G, Sozzi G, Silva M, Sverzellati N, Galeone C, La Vecchia C, Ghirardi A, Corrao G. Stopping Smoking Reduces Mortality in Low-Dose Computed Tomography Screening Participants. J Thorac Oncol. 2016 May;11(5):693-699. doi: 10.1016/j.jtho.2016.02.011. Epub 2016 Feb 24. PMID 26921675
- BACKGROUNDPastorino U, Morelli D, Marchiano A, Sestini S, Suatoni P, Taverna F, Boeri M, Sozzi G, Cantarutti A, Corrao G. Inflammatory status and lung function predict mortality in lung cancer screening participants. Eur J Cancer Prev. 2018 Jul;27(4):289-295. doi: 10.1097/CEJ.0000000000000342. PMID 28333763
- BACKGROUNDPastorino U, Morelli D, Leuzzi G, Gisabella M, Suatoni P, Taverna F, Bertocchi E, Boeri M, Sozzi G, Cantarutti A, Corrao G. Baseline and postoperative C-reactive protein levels predict mortality in operable lung cancer. Eur J Cancer. 2017 Jul;79:90-97. doi: 10.1016/j.ejca.2017.03.020. Epub 2017 May 1. PMID 28472743
- BACKGROUNDLa Vecchia C, Gallus S, Garattini S. Effects of physical inactivity on non-communicable diseases. Lancet. 2012 Nov 3;380(9853):1553; author reply 1553-4. doi: 10.1016/S0140-6736(12)61872-8. No abstract available. PMID 23122239
- BACKGROUNDBonaccio M, Cerletti C, Iacoviello L, de Gaetano G. Mediterranean diet and low-grade subclinical inflammation: the Moli-sani study. Endocr Metab Immune Disord Drug Targets. 2015;15(1):18-24. doi: 10.2174/1871530314666141020112146. PMID 25329200
- BACKGROUNDLee Y, Kang D, Lee SA. Effect of dietary patterns on serum C-reactive protein level. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1004-11. doi: 10.1016/j.numecd.2014.05.001. Epub 2014 May 27. PMID 24998076
- BACKGROUNDBosetti C, Gallus S, Peto R, Negri E, Talamini R, Tavani A, Franceschi S, La Vecchia C. Tobacco smoking, smoking cessation, and cumulative risk of upper aerodigestive tract cancers. Am J Epidemiol. 2008 Feb 15;167(4):468-73. doi: 10.1093/aje/kwm318. Epub 2007 Dec 4.