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Screening and Multiple Intervention on Lung Epidemics
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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).
Official title: Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial
Key Details
Gender
All
Age Range
55 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2019-07-23
Completion Date
2026-12-31
Last Updated
2026-03-27
Healthy Volunteers
Yes
Interventions
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
Locations (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy