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Trial record 9 of 9 for:    CYTISINE

Screening and Multiple Intervention on Lung Epidemics (SMILE)

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ClinicalTrials.gov Identifier: NCT03654105
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Istituto Di Ricerche Farmacologiche Mario Negri
Information provided by (Responsible Party):
Ugo Pastorino, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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).

Condition or disease Intervention/treatment Phase
Inflammation Smoking Cessation Diet Modification Physical Activity Lung Cancer 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 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Smoking cessation and Antinflammatory
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

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.

Other Name: ev code SUB31171

Drug: Acetylsalicylic acid
The treatment will consist of Acetylsalicylic acid at 100mg once a day
Other Name: Cardioaspirin

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

Experimental: Smoking cessation
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

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.

Other Name: ev code SUB31171

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

Experimental: Antinflammatory
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
The treatment will consist of Acetylsalicylic acid at 100mg once a day
Other Name: Cardioaspirin

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

Control Group
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
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




Primary Outcome Measures :
  1. Change in chronic inflammatory status [ Time Frame: 1 year ]
    Reduction in the percentage of subjects with CRP>=2 mg/L


Secondary Outcome Measures :
  1. Change in smoking status [ Time Frame: 1 year ]
    Reduction in the percentage of smokers

  2. Change in dietary habits [ Time Frame: 1 year ]

    Dietary intakes are collected by a self reported food frequencies questionnaire and data are expressed as the average daily/weekly consumption of foods and food groups.

    Servings size is defined as "natural unit" (e.g. 1 glass of soft drinks, 1 teaspoon of sugar) or as an average serving (e.g. 80 g of pasta or rice, 30 g of dried fruits).

    The frequency of serving size is reported as continuous measure. Data will be collected as continuous measures and will be analyzed by performing statistical models to investigate a potential relationship among changes in dietary habits and anthropometric parameters (BMI, waist circumference..), socio-demographic characteristics (gender, smoking status, physical activity), biochemical parameters (CRP blood levels), drugs assumption and the risk of chronic diseases, such as lung cancer.


  3. Change in the physical activity [ Time Frame: 1 year ]

    Increase in the physical activity measured by the validate short form IPAQ questionnaire (International Physical Activity Questionnaire) The items in the short IPAQ form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each activity.

    METs are multiples of the resting metabolic rate and a MET-minute is computed by multiplying the MET score of an activity by the minutes performed:

    • Walking MET-minutes/week = 3.3 * walking minutes * walking days
    • Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days
    • Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days
    • Total physical activity MET-minutes/week = sum of Walking + Moderate + Vigorous MET-minutes/week scores

  4. Change in body mass index (BMI) [ Time Frame: 1 year ]
    Weight and height will be combined to report BMI in kg/m^2. Reduction in BMI

  5. Change in waist circumference [ Time Frame: 1 year ]
    Reduction in waist circumference expressed in centimeters

  6. Change in metabolic profile [ Time Frame: 1 year ]
    Enhancement in blood glucose, total cholesterol, LDL, HDL and triglycerides

  7. Change in lung cancer incidence [ Time Frame: 3 years ]
    Reduction in lung cancer incidence

  8. Change in lung cancer specific and overall mortality [ Time Frame: 3 years ]
    Reduction in lung cancer specific and overall mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654105


Locations
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Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Istituto Di Ricerche Farmacologiche Mario Negri
Investigators
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Principal Investigator: Ugo Pastorino, MD IRCCS IstitutoNazionale dei Tumori di Milano

Additional Information:
Publications:
Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju ShN, Wormser D, Gao P, Kaptoge S, Berrington de Gonzalez A, Cairns BJ, Huxley R, Jackson ChL, Joshy G, Lewington S, Manson JE, Murphy N, Patel AV, Samet JM, Woodward M, Zheng W, Zhou M, Bansal N, Barricarte A, Carter B, Cerhan JR, Smith GD, Fang X, Franco OH, Green J, Halsey J, Hildebrand JS, Jung KJ, Korda RJ, McLerran DF, Moore SC, O'Keeffe LM, Paige E, Ramond A, Reeves GK, Rolland B, Sacerdote C, Sattar N, Sofianopoulou E, Stevens J, Thun M, Ueshima H, Yang L, Yun YD, Willeit P, Banks E, Beral V, Chen Zh, Gapstur SM, Gunter MJ, Hartge P, Jee SH, Lam TH, Peto R, Potter JD, Willett WC, Thompson SG, Danesh J, Hu FB. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016 Aug 20;388(10046):776-86. doi: 10.1016/S0140-6736(16)30175-1. Epub 2016 Jul 13.

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Responsible Party: Ugo Pastorino, Head of Thoracic Surgery Division, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03654105     History of Changes
Other Study ID Numbers: 2016-003036-20
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ugo Pastorino, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Inflammation
Primary Prevention
Multiple Prevention
Lung Cancer Screening
Smoking Cessation
Diet
Physical Activity
CRP

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics