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).

Conditions

• Inflammation
• Smoking Cessation
• Diet Modification
• Physical Activity
• Lung Cancer

Interventions

DRUG

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.

DRUG

Acetylsalicylic acid

The treatment will consist of Acetylsalicylic acid at 100mg once a day

OTHER

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.

DIAGNOSTIC_TEST

early lung cancer detection

standard treatment for early lung cancer detection with ultra low dose CT

DIAGNOSTIC_TEST

spirometry with CO test

spirometry with CO test

OTHER

anthropometic data collection

anthropometic data collection

OTHER

blood test

blood test to assess the metabolic and inflammatory profile

Sponsors & Collaborators

• Istituto Di Ricerche Farmacologiche Mario Negri

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Ugo Pastorino, MD · IRCCS IstitutoNazionale dei Tumori di Milano

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

55 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-23

Primary Completion

2024-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations