Skip to content

A randomized trial of multi-factorial primary prevention in high risk subjects candidate to a lung cancer early detection CT program

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513660-26-00
Acronym
SMILE
Enrollment
2000
Registered
2024-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects at high risk of inflammatory state and mortality from lung cancer, other cancers and all causes

Brief summary

Reduction in the percentage of subjects with PCR ≥2 mg/L after one year of treatment in the interventional groups versus control group.

Detailed description

Reduction of the proportion of smokers after one year of follow-up in the intervention group on smoking cessation over the control group, Greater adherence to the Mediterranean Diet, measured through specific indexes defined in scientific literature (such as the MDS), The inflammatory status group with respect to the control group, Increased physical activity, quantified in terms of Metabolic Equivalence of the Task (MET) in the inflammatory response group compared to the control group, Reduction of the various anthropometric parameters (IMC, waist circumference, waist circumference / waist ratio) and greater prevalence of weight-weight subjects in the inflammatory intervention group versus the control group, Reduction of cardio-metabolic markers in the blood in the inflammatory group compared to the control group, Better quality of life, quantified by SF- 12 in intervention groups compared to control group, Reduction of the incidence rate of lung cancer in the intervention group on smoking cessation with respect to the control group, Reduction of the total mortality rate in the intervention groups compared to the control group, Evaluation of the relationship between inflammatory profile (PCR) plasma biomarkers and cardio-metabolic profile and microRNA profile, Reduction in percentage of smokers and adverse reactions after one year of follow-up in subjects treated with Cytisine with prolonged administration compared to standard drug administration

Interventions

DRUGTabex 1
DRUG5 mg tabletki powlekane

Sponsors

Fondazione IRCCS Istituto Nazionale Dei Tumori
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reduction in the percentage of subjects with PCR ≥2 mg/L after one year of treatment in the interventional groups versus control group.

Secondary

MeasureTime frame
Reduction of the proportion of smokers after one year of follow-up in the intervention group on smoking cessation over the control group, Greater adherence to the Mediterranean Diet, measured through specific indexes defined in scientific literature (such as the MDS), The inflammatory status group with respect to the control group, Increased physical activity, quantified in terms of Metabolic Equivalence of the Task (MET) in the inflammatory response group compared to the control group, Reduction of the various anthropometric parameters (IMC, waist circumference, waist circumference / waist ratio) and greater prevalence of weight-weight subjects in the inflammatory intervention group versus the control group, Reduction of cardio-metabolic markers in the blood in the inflammatory group compared to the control group, Better quality of life, quantified by SF- 12 in intervention groups compared to control group, Reduction of the incidence rate of lung cancer in the intervention group on sm

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026