Screening and Multiple Intervention on Lung Epidemics

NCT03654105 | Active Not Recruiting Phase 2

• 1 other identifier: 2016-003036-20
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Inflammation; Primary Prevention; Multiple Prevention; Lung Cancer Screening; Smoking Cessation; Diet; Physical Activity; CRP

Outcome Measures

Primary Outcomes (1)

• Change in chronic inflammatory status

  Reduction in the percentage of subjects with CRP\>=2 mg/L

  1 year

Secondary Outcomes (8)

• Change in smoking status

  1 year

• Change in dietary habits

  1 year

• Change in the physical activity

  1 year

• Change in body mass index (BMI)

  1 year

• Change in waist circumference

  1 year

Study Arms (4)

Smoking cessation and Antinflammatory

EXPERIMENTAL

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

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

Smoking cessation

EXPERIMENTAL

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

Drug: Cytisine; Diagnostic Test: early lung cancer detection; Diagnostic Test: spirometry with CO test; Other: anthropometic data collection; Other: blood test

Antinflammatory

EXPERIMENTAL

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

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

Control Group

OTHER

standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test

Diagnostic Test: early lung cancer detection; Diagnostic Test: spirometry with CO test; Other: anthropometic data collection; Other: blood test

Interventions

Cytisine DRUG

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.

Also known as: ev code SUB31171

Smoking cessation; Smoking cessation and Antinflammatory

Acetylsalicylic acid DRUG

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

Also known as: Cardioaspirin

Antinflammatory; Smoking cessation and Antinflammatory

Diet Modification and Physical Activity Increase OTHER

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.

Antinflammatory; Smoking cessation and Antinflammatory

early lung cancer detection DIAGNOSTIC_TEST

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

Antinflammatory; Control Group; Smoking cessation; Smoking cessation and Antinflammatory

spirometry with CO test DIAGNOSTIC_TEST

spirometry with CO test

Antinflammatory; Control Group; Smoking cessation; Smoking cessation and Antinflammatory

anthropometic data collection OTHER

anthropometic data collection

Antinflammatory; Control Group; Smoking cessation; Smoking cessation and Antinflammatory

blood test OTHER

blood test to assess the metabolic and inflammatory profile

Antinflammatory; Control Group; Smoking cessation; Smoking cessation and Antinflammatory

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

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Related Links

• WHO report on the global tobacco epidemic, 2015
• Ministero della Salute, Istituto Superiore di Sanità. Linee guida cliniche per promuovere la cessazione dell'abitudine al fumo. Guida breve per la realizzazione degli interventi.
• AIRC. Fumo: le domande più frequenti. Perché si insiste tanto sui rischi del fumo?

MeSH Terms

Conditions

Inflammation; Smoking Cessation; Motor Activity; Lung Neoplasms

Interventions

cytisine; Aspirin; Diet Therapy; Spirometry; Hematologic Tests

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nutrition Therapy; Therapeutics; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Ugo Pastorino, MD

  IRCCS IstitutoNazionale dei Tumori di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Thoracic Surgery Division

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 31, 2018
• Study Start: July 23, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)