Screening and Multiple Intervention on Lung Epidemics (NCT03654105) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Screening and Multiple Intervention on Lung Epidemics
Italy2,000 participantsStarted 2019-07-23
Plain-language 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).
Who can participate
Age range55 Years – 75 Years
SexALL
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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)
What they're measuring
1
Change in chronic inflammatory status
Timeframe: 1 year
Trial details
NCT IDNCT03654105
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano