Screening and Multiple Intervention on Lung Epidemics

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).

Timeline

Start

2019-07-23

Primary completion

2024-12-31

Completion

2026-12-31

Publications

• Background Pastorino 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.
• Background Pastorino 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.
• Background Pastorino 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.
• Background La 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.
• Background Bonaccio 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.
• Background Lee 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.
• Background Bosetti 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.
• Background Gallus S, Muttarak R, Martinez-Sanchez JM, Zuccaro P, Colombo P, La Vecchia C. Smoking prevalence and smoking attributable mortality in Italy, 2010. Prev Med. 2011 Jun;52(6):434-8. doi: 10.1016/j.ypmed.2011.03.011. Epub 2011 Mar 21.
• Background Linseisen J, Rohrmann S, Miller AB, Bueno-de-Mesquita HB, Buchner FL, Vineis P, Agudo A, Gram IT, Janson L, Krogh V, Overvad K, Rasmuson T, Schulz M, Pischon T, Kaaks R, Nieters A, Allen NE, Key TJ, Bingham S, Khaw KT, Amiano P, Barricarte A, Martinez C, Navarro C, Quiros R, Clavel-Chapelon F, Boutron-Ruault MC, Touvier M, Peeters PH, Berglund G, Hallmans G, Lund E, Palli D, Panico S, Tumino R, Tjonneland A, Olsen A, Trichopoulou A, Trichopoulos D, Autier P, Boffetta P, Slimani N, Riboli E. Fruit and vegetable consumption and lung cancer risk: updated information from the European Prospective Investigation into Cancer and Nutrition (EPIC). Int J Cancer. 2007 Sep 1;121(5):1103-14. doi: 10.1002/ijc.22807.
• Background Lugo A, Asciutto R, Pacifici R, Colombo P, La Vecchia C, Gallus S. Smoking in Italy 2013-2014, with a focus on the young. Tumori. 2015 Sep-Oct;101(5):529-34. doi: 10.5301/tj.5000311. Epub 2015 May 15.
• Background Peto J. Cancer epidemiology in the last century and the next decade. Nature. 2001 May 17;411(6835):390-5. doi: 10.1038/35077256.
• Background Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
• Background Carter BD, Abnet CC, Feskanich D, Freedman ND, Hartge P, Lewis CE, Ockene JK, Prentice RL, Speizer FE, Thun MJ, Jacobs EJ. Smoking and mortality--beyond established causes. N Engl J Med. 2015 Feb 12;372(7):631-40. doi: 10.1056/NEJMsa1407211.
• Background Muezzinler A, Mons U, Gellert C, Schottker B, Jansen E, Kee F, O'Doherty MG, Kuulasmaa K, Freedman ND, Abnet CC, Wolk A, Hakansson N, Orsini N, Wilsgaard T, Bueno-de-Mesquita B, van der Schouw YT, Peeters PHM, de Groot LCPGM, Peters A, Orfanos P, Linneberg A, Pisinger C, Tamosiunas A, Baceviciene M, Luksiene D, Bernotiene G, Jousilahti P, Petterson-Kymmer U, Jansson JH, Soderberg S, Eriksson S, Jankovic N, Sanchez MJ, Veronesi G, Sans S, Drygas W, Trichopoulou A, Boffetta P, Brenner H. Smoking and All-cause Mortality in Older Adults: Results From the CHANCES Consortium. Am J Prev Med. 2015 Nov;49(5):e53-e63. doi: 10.1016/j.amepre.2015.04.004. Epub 2015 Jul 15.
• Background Thun MJ, Carter BD, Feskanich D, Freedman ND, Prentice R, Lopez AD, Hartge P, Gapstur SM. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013 Jan 24;368(4):351-64. doi: 10.1056/NEJMsa1211127.
• Background Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
• Background Peto R, Darby S, Deo H, Silcocks P, Whitley E, Doll R. Smoking, smoking cessation, and lung cancer in the UK since 1950: combination of national statistics with two case-control studies. BMJ. 2000 Aug 5;321(7257):323-9. doi: 10.1136/bmj.321.7257.323.
• Background Gallus S, La Vecchia C, Levi F, Simonato L, Dal Maso L, Franceschi S. Leanness and squamous cell oesophageal cancer. Ann Oncol. 2001 Jul;12(7):975-9. doi: 10.1023/a:1011104809985.
• Background Franceschi S, Dal Maso L, Levi F, Conti E, Talamini R, La Vecchia C. Leanness as early marker of cancer of the oral cavity and pharynx. Ann Oncol. 2001 Mar;12(3):331-6. doi: 10.1023/a:1011191809335.
• Background Duan P, Hu C, Quan C, Yi X, Zhou W, Yuan M, Yu T, Kourouma A, Yang K. Body mass index and risk of lung cancer: Systematic review and dose-response meta-analysis. Sci Rep. 2015 Nov 19;5:16938. doi: 10.1038/srep16938.
• Background Kabat GC, Kim M, Hunt JR, Chlebowski RT, Rohan TE. Body mass index and waist circumference in relation to lung cancer risk in the Women's Health Initiative. Am J Epidemiol. 2008 Jul 15;168(2):158-69. doi: 10.1093/aje/kwn109. Epub 2008 May 15.
• Background Lam TK, Moore SC, Brinton LA, Smith L, Hollenbeck AR, Gierach GL, Freedman ND. Anthropometric measures and physical activity and the risk of lung cancer in never-smokers: a prospective cohort study. PLoS One. 2013 Aug 5;8(8):e70672. doi: 10.1371/journal.pone.0070672. Print 2013.
• Background Etemadi A, O'Doherty MG, Freedman ND, Hollenbeck AR, Dawsey SM, Abnet CC. A prospective cohort study of body size and risk of head and neck cancers in the NIH-AARP diet and health study. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2422-9. doi: 10.1158/1055-9965.EPI-14-0709-T. Epub 2014 Aug 29.
• Background Gaudet MM, Kitahara CM, Newton CC, Bernstein L, Reynolds P, Weiderpass E, Kreimer AR, Yang G, Adami HO, Alavanja MC, Beane Freeman LE, Boeing H, Buring J, Chaturvedi A, Chen Y, D'Aloisio AA, Freedman M, Gao YT, Gaziano JM, Giles GG, Hakansson N, Huang WY, Lee IM, Linet MS, MacInnis RJ, Park Y, Prizment A, Purdue MP, Riboli E, Robien K, Sandler DP, Schairer C, Sesso HD, Ou Shu X, White E, Wolk A, Xiang YB, Zelenuich-Jacquotte A, Zheng W, Patel AV, Hartge P, Berrington de Gonzalez A, Gapstur SM. Anthropometry and head and neck cancer:a pooled analysis of cohort data. Int J Epidemiol. 2015 Apr;44(2):673-81. doi: 10.1093/ije/dyv059. Epub 2015 Jun 6.
• Background Anandavadivelan P, Lagergren P. Cachexia in patients with oesophageal cancer. Nat Rev Clin Oncol. 2016 Mar;13(3):185-98. doi: 10.1038/nrclinonc.2015.200. Epub 2015 Nov 17.
• Background Andersson BA, Lewin F, Lundgren J, Nilsson M, Rutqvist LE, Lofgren S, Laytragoon-Lewin N. Plasma tumor necrosis factor-alpha and C-reactive protein as biomarker for survival in head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2014 Mar;140(3):515-9. doi: 10.1007/s00432-014-1592-8. Epub 2014 Jan 31.
• Background Xia WX, Ye YF, Lu X, Wang L, Ke LR, Zhang HB, Roycik MD, Yang J, Shi JL, Cao KJ, Guo X, Xiang YQ. The impact of baseline serum C-reactive protein and C-reactive protein kinetics on the prognosis of metastatic nasopharyngeal carcinoma patients treated with palliative chemotherapy. PLoS One. 2013 Oct 10;8(10):e76958. doi: 10.1371/journal.pone.0076958. eCollection 2013.
• Background Hong S, Kang YA, Cho BC, Kim DJ. Elevated serum C-reactive protein as a prognostic marker in small cell lung cancer. Yonsei Med J. 2012 Jan;53(1):111-7. doi: 10.3349/ymj.2012.53.1.111.
• Background Dai J, Tang K, Xiao W, Yu G, Zeng J, Li W, Zhang YQ, Xu H, Chen ZQ, Ye ZQ. Prognostic significance of C-reactive protein in urological cancers: a systematic review and meta-analysis. Asian Pac J Cancer Prev. 2014;15(8):3369-75. doi: 10.7314/apjcp.2014.15.8.3369.
• Background Santos S, Oliveira A, Lopes C. Systematic review of saturated fatty acids on inflammation and circulating levels of adipokines. Nutr Res. 2013 Sep;33(9):687-95. doi: 10.1016/j.nutres.2013.07.002. Epub 2013 Aug 6.
• Background Trichopoulou A, Kouris-Blazos A, Wahlqvist ML, Gnardellis C, Lagiou P, Polychronopoulos E, Vassilakou T, Lipworth L, Trichopoulos D. Diet and overall survival in elderly people. BMJ. 1995 Dec 2;311(7018):1457-60. doi: 10.1136/bmj.311.7018.1457.
• Background Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. doi: 10.1186/1471-2288-3-26.
• Background Pastorino U, Bellomi M, Landoni C, De Fiori E, Arnaldi P, Picchio M, Pelosi G, Boyle P, Fazio F. Early lung-cancer detection with spiral CT and positron emission tomography in heavy smokers: 2-year results. Lancet. 2003 Aug 23;362(9384):593-7. doi: 10.1016/S0140-6736(03)14188-8.
• Background Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju ShN, Wormser D, Gao P, Kaptoge S, Berrington de Gonzalez A, Cairns BJ, Huxley R, Jackson ChL, Joshy G, Lewington S, Manson JE, Murphy N, Patel AV, Samet JM, Woodward M, Zheng W, Zhou M, Bansal N, Barricarte A, Carter B, Cerhan JR, Smith GD, Fang X, Franco OH, Green J, Halsey J, Hildebrand JS, Jung KJ, Korda RJ, McLerran DF, Moore SC, O'Keeffe LM, Paige E, Ramond A, Reeves GK, Rolland B, Sacerdote C, Sattar N, Sofianopoulou E, Stevens J, Thun M, Ueshima H, Yang L, Yun YD, Willeit P, Banks E, Beral V, Chen Zh, Gapstur SM, Gunter MJ, Hartge P, Jee SH, Lam TH, Peto R, Potter JD, Willett WC, Thompson SG, Danesh J, Hu FB. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016 Aug 20;388(10046):776-86. doi: 10.1016/S0140-6736(16)30175-1. Epub 2016 Jul 13.
• Background West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard P, Stapleton J. Placebo-controlled trial of cytisine for smoking cessation. N Engl J Med. 2011 Sep 29;365(13):1193-200. doi: 10.1056/NEJMoa1102035.
• Background Walker N, Howe C, Glover M, McRobbie H, Barnes J, Nosa V, Parag V, Bassett B, Bullen C. Cytisine versus nicotine for smoking cessation. N Engl J Med. 2014 Dec 18;371(25):2353-62. doi: 10.1056/NEJMoa1407764.
• Background Walker N, Bullen C, Barnes J, McRobbie H, Tutka P, Raw M, Etter JF, Siddiqi K, Courtney RJ, Castaldelli-Maia JM, Selby P, Sheridan J, Rigotti NA. Getting cytisine licensed for use world-wide: a call to action. Addiction. 2016 Nov;111(11):1895-1898. doi: 10.1111/add.13464. Epub 2016 Jul 17. No abstract available.

Drugs

Indications