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Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169271
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Current Smoker
Former Smoker
Multiple Pulmonary Nodules
Tobacco Use Disorder
Interventions Drug: Aspirin
Other: Laboratory Biomarker Analysis
Other: Placebo
Enrollment 109
Recruitment Details A total of 619 ld-CT scans, belonging to the lung screening programs, showed potentially eligible nodules. A total of 109 subjects signed a written informed consent and underwent baseline visit while 98 have been randomized.
Pre-assignment Details After enrollment, 11 participants were not randomized (baseline screening failures)
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description 1 tablet of aspirin 100 mg a day for one year 1 tablet of placebo a day for one year
Period Title: Overall Study
Started 49 49
Completed 48 47
Not Completed 1 2
Reason Not Completed
Protocol Violation             1             2
Arm/Group Title Aspirin Placebo Total
Hide Arm/Group Description 1 tablet of aspirin 100 mg a day for one year 1 tablet of placebo a day for one year Total of all reporting groups
Overall Number of Baseline Participants 49 49 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  51.0%
24
  49.0%
49
  50.0%
>=65 years
24
  49.0%
25
  51.0%
49
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 49 participants 98 participants
64.6  (4.1) 64.6  (4.7) 64.6  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Female
28
  57.1%
27
  55.1%
55
  56.1%
Male
21
  42.9%
22
  44.9%
43
  43.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
49
 100.0%
49
 100.0%
98
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 49 participants 98 participants
United States 1 0 1
Italy 48 49 97
Sum of longest diameters of baseline target nodules  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 49 participants 49 participants 98 participants
8.5  (4.3) 11  (11.3) 9.8  (8.6)
Sum of diameters of baseline target nodules  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 49 participants 49 participants 98 participants
6.8  (2.8) 7.2  (2.7) 7.0  (2.8)
Baseline lesion volume  
Mean (Standard Deviation)
Unit of measure:  Millimeter^3
Number Analyzed 49 participants 49 participants 98 participants
138  (139) 151  (151) 145  (145)
Baseline lesion density  
Mean (Standard Deviation)
Unit of measure:  Hounsfield Unit
Number Analyzed 49 participants 49 participants 98 participants
-628  (76) -663  (98) -647  (90)
Circulating biomarkers and miRNA risk score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 49 participants 49 participants 98 participants
10.4  (9.5) 10  (10.6) 10.2  (10)
[1]
Measure Description: Scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value<0 is considered negative, a value ≥0 positive for lung cancer.
Circulating Thromboxane  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 49 participants 49 participants 98 participants
60.4  (32.6) 61.1  (37.3) 60.8  (34.8)
Circulating Prostaglandin E metabolite (PGEM) normalized to uCr concentration  
Mean (Standard Deviation)
Unit of measure:  Pg/mg creatinine
Number Analyzed 49 participants 49 participants 98 participants
385  (218) 334  (213) 359  (216)
Circulating Leukotriene E4 normalized to uCr concentration  
Mean (Standard Deviation)
Unit of measure:  Pg/mg creatinine
Number Analyzed 49 participants 49 participants 98 participants
1701  (1670) 1226  (909) 1463  (1359)
Circulating High sensitive CRP  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 49 participants 49 participants 98 participants
0.47  (1.01) 0.29  (0.52) 0.38  (0.8)
1.Primary Outcome
Title Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
Hide Description Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
Time Frame Twelve-month treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
0.3  (2.54) -0.12  (1.55)
2.Secondary Outcome
Title Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
Hide Description Difference (12 month-baseline) in the sum of baseline target nodules diameters
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: millimeter (mm)
0.1  (2.4) -0.1  (1.1)
3.Secondary Outcome
Title Change in Lesion Volume
Hide Description Difference (12 month-baseline) in lesion volume
Time Frame Baseline to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: millimiter^3 (mm3)
-4.5  (78) -4.8  (134)
4.Secondary Outcome
Title Change in Lesion Density
Hide Description Difference (12 month-baseline) in lesion density
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: Hounsfield unit (HU)
24  (65) 28  (78)
5.Secondary Outcome
Title Modulation of Thromboxane B2
Hide Description Difference (12 month-baseline) in biomarker concentration
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: ng/mL
-35.8  (53.4) 20.5  (50.7)
6.Secondary Outcome
Title Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
Hide Description Difference (12 month-baseline) in biomarker concentration
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: pg/mg creatinine
-60.7  (210) 29.8  (215)
7.Secondary Outcome
Title Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
Hide Description Difference (12 month-baseline) in biomarker concentration
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: pg/mg creatinine
-235  (1240) -9  (592)
8.Secondary Outcome
Title Modulation of High Sensitive CRP
Hide Description Difference (12 month-baseline) in biomarker concentration
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.12  (0.88) -0.08  (0.5)
9.Secondary Outcome
Title Modulation of miRNA Prediction Risk Score
Hide Description Difference (12 month-baseline) of the score on a scale (scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value<0 is considered negative, a value ≥0 positive for lung cancer).
Time Frame Baseline up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:
1 tablet of aspirin 100 mg a day for one year
1 tablet of placebo a day for one year
Overall Number of Participants Analyzed 49 49
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.14  (8.94) 0.36  (7.36)
Time Frame Baseline up to 13 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description 1 tablet of aspirin 100 mg a day for one year 1 tablet of placebo a day for one year
All-Cause Mortality
Aspirin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/49 (0.00%)    
Hide Serious Adverse Events
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/49 (16.33%)      4/49 (8.16%)    
Gastrointestinal disorders     
Hemorrhoids   1/49 (2.04%)  1 0/49 (0.00%)  0
Infections and infestations     
Balanitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung cancer   2/49 (4.08%)  2 2/49 (4.08%)  2
Increased volume of target lesion  [1]  0/49 (0.00%)  0 1/49 (2.04%)  1
Bladder cancer   2/49 (4.08%)  3 0/49 (0.00%)  0
Liposarcoma   1/49 (2.04%)  1 0/49 (0.00%)  0
Surgical and medical procedures     
Anal fissures   1/49 (2.04%)  1 0/49 (0.00%)  0
Penile implant   0/49 (0.00%)  0 1/49 (2.04%)  1
Indicates events were collected by systematic assessment
[1]
Neoplasms benign, malignant and unspecified (including cuysts and polyps)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/49 (87.76%)      41/49 (83.67%)    
Blood and lymphatic system disorders     
Leukocytosis   1/49 (2.04%)  1 0/49 (0.00%)  0
Cardiac disorders     
Sinus tachycardia   0/49 (0.00%)  0 2/49 (4.08%)  2
Ear and labyrinth disorders     
Ear pain   1/49 (2.04%)  1 0/49 (0.00%)  0
Vertigo   2/49 (4.08%)  2 0/49 (0.00%)  0
Other   1/49 (2.04%)  1 0/49 (0.00%)  0
Eye disorders     
Blurred vision   0/49 (0.00%)  0 1/49 (2.04%)  1
Conjunctivitis   1/49 (2.04%)  1 1/49 (2.04%)  1
Vitreous hemorrage   0/49 (0.00%)  0 1/49 (2.04%)  1
Other   2/49 (4.08%)  4 1/49 (2.04%)  1
Gastrointestinal disorders     
Dyspepsia   4/49 (8.16%)  5 1/49 (2.04%)  1
Gastroesophageal reflux disease   1/49 (2.04%)  1 2/49 (4.08%)  2
Abdominal pain   1/49 (2.04%)  1 0/49 (0.00%)  0
Oral hemorrage   1/49 (2.04%)  1 0/49 (0.00%)  0
Periodontal disease   2/49 (4.08%)  2 0/49 (0.00%)  0
Diarrhea   7/49 (14.29%)  7 2/49 (4.08%)  2
Lower gastrointestinal hemorrage   1/49 (2.04%)  1 0/49 (0.00%)  0
Stomach pain   4/49 (8.16%)  5 3/49 (6.12%)  6
Hemorroidal hemorrage   2/49 (4.08%)  2 2/49 (4.08%)  6
Colitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Gastrointestinal pain   1/49 (2.04%)  2 2/49 (4.08%)  3
Toothache   0/49 (0.00%)  0 5/49 (10.20%)  5
Gastritis   0/49 (0.00%)  0 1/49 (2.04%)  1
Vomiting   0/49 (0.00%)  0 1/49 (2.04%)  1
Hemorroids   0/49 (0.00%)  0 1/49 (2.04%)  1
Gastrointestinal disorder, other   1/49 (2.04%)  1 2/49 (4.08%)  2
General disorders     
Flu-like symptoms   5/49 (10.20%)  5 7/49 (14.29%)  8
Localized edema   1/49 (2.04%)  1 0/49 (0.00%)  0
Non-cardia chest pain   0/49 (0.00%)  0 1/49 (2.04%)  1
Fever   0/49 (0.00%)  0 1/49 (2.04%)  1
Malaise   0/49 (0.00%)  0 1/49 (2.04%)  2
Infections and infestations     
Upper respiratory infection   3/49 (6.12%)  6 4/49 (8.16%)  4
Otitis externa   1/49 (2.04%)  1 0/49 (0.00%)  0
Bronchial infection   10/49 (20.41%)  18 5/49 (10.20%)  10
Urinary tract infection   4/49 (8.16%)  8 0/49 (0.00%)  0
Tooth infection   2/49 (4.08%)  2 2/49 (4.08%)  2
Penile Infection   1/49 (2.04%)  1 0/49 (0.00%)  0
Laryingitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Nail infection   1/49 (2.04%)  1 0/49 (0.00%)  0
Otitis media   0/49 (0.00%)  0 2/49 (4.08%)  2
Conjunctivitis infective   0/49 (0.00%)  0 1/49 (2.04%)  1
Other   3/49 (6.12%)  3 2/49 (4.08%)  2
Injury, poisoning and procedural complications     
Fall   1/49 (2.04%)  1 0/49 (0.00%)  0
Fracture   0/49 (0.00%)  0 1/49 (2.04%)  1
Other   1/49 (2.04%)  2 1/49 (2.04%)  1
Investigations     
Cholesterol high   1/49 (2.04%)  1 0/49 (0.00%)  0
ALT increased   1/49 (2.04%)  1 0/49 (0.00%)  0
AST increased   1/49 (2.04%)  1 0/49 (0.00%)  0
Bilirubin increased   2/49 (4.08%)  2 2/49 (4.08%)  2
Other   1/49 (2.04%)  1 1/49 (2.04%)  1
Metabolism and nutrition disorders     
Hyperglycemia   1/49 (2.04%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain in extremity   2/49 (4.08%)  2 1/49 (2.04%)  2
Arthralgia   3/49 (6.12%)  7 7/49 (14.29%)  13
Back pain   4/49 (8.16%)  4 6/49 (12.24%)  13
Neck pain   2/49 (4.08%)  3 1/49 (2.04%)  2
Myalgia   1/49 (2.04%)  2 1/49 (2.04%)  1
Other   0/49 (0.00%)  0 1/49 (2.04%)  1
Chest wall pain   0/49 (0.00%)  0 4/49 (8.16%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Other   2/49 (4.08%)  2 2/49 (4.08%)  2
Nervous system disorders     
Headache   7/49 (14.29%)  10 4/49 (8.16%)  12
Paresthesia   2/49 (4.08%)  5 1/49 (2.04%)  1
Dizziness   0/49 (0.00%)  0 1/49 (2.04%)  2
Other   0/49 (0.00%)  0 1/49 (2.04%)  1
Psychiatric disorders     
Insomnia   0/49 (0.00%)  0 2/49 (4.08%)  2
Other   1/49 (2.04%)  2 0/49 (0.00%)  0
Renal and urinary disorders     
Hematuria   2/49 (4.08%)  2 0/49 (0.00%)  0
Cystitis noninfective   1/49 (2.04%)  2 4/49 (8.16%)  6
Hemoglobinuria   1/49 (2.04%)  1 0/49 (0.00%)  0
Proteinuria   1/49 (2.04%)  1 0/49 (0.00%)  0
Renal colic   2/49 (4.08%)  3 0/49 (0.00%)  0
Urinary frequency   0/49 (0.00%)  0 1/49 (2.04%)  1
Reproductive system and breast disorders     
Vaginal hemorrage   1/49 (2.04%)  1 0/49 (0.00%)  0
Prostatic pain   1/49 (2.04%)  1 0/49 (0.00%)  0
Vagynal dryness   0/49 (0.00%)  0 1/49 (2.04%)  2
Breast pain   0/49 (0.00%)  0 1/49 (2.04%)  1
Other   2/49 (4.08%)  2 2/49 (4.08%)  2
Respiratory, thoracic and mediastinal disorders     
Nasal congestion   5/49 (10.20%)  7 6/49 (12.24%)  9
Epistaxix   2/49 (4.08%)  5 0/49 (0.00%)  0
Pharyngolaryngeal pain   1/49 (2.04%)  1 0/49 (0.00%)  0
Cough   6/49 (12.24%)  10 7/49 (14.29%)  8
Laryngeal inflammation   1/49 (2.04%)  1 0/49 (0.00%)  0
Bronchial obstruction   1/49 (2.04%)  1 0/49 (0.00%)  0
Dyspnea   1/49 (2.04%)  1 0/49 (0.00%)  0
Bronchospasm   0/49 (0.00%)  0 2/49 (4.08%)  2
Sore theroat   0/49 (0.00%)  0 1/49 (2.04%)  1
Hoarseness   0/49 (0.00%)  0 1/49 (2.04%)  1
Skin and subcutaneous tissue disorders     
Erythroderma   1/49 (2.04%)  1 0/49 (0.00%)  0
Pruritus   0/49 (0.00%)  0 1/49 (2.04%)  1
Other   2/49 (4.08%)  2 2/49 (4.08%)  3
Surgical and medical procedures     
Other   4/49 (8.16%)  5 4/49 (8.16%)  4
Vascular disorders     
Hematoma   2/49 (4.08%)  3 0/49 (0.00%)  0
Phlebitis   1/49 (2.04%)  1 0/49 (0.00%)  0
Hypertension   4/49 (8.16%)  4 3/49 (6.12%)  18
Other   0/49 (0.00%)  0 1/49 (2.04%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Therese Bevers / Clinical Cancer Prevention Department
Organization: UT MD Anderson Cancer Center
Phone: 713-745-8048
EMail: tbevers@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02169271    
Obsolete Identifiers: NCT02135497
Other Study ID Numbers: NCI-2014-01311
NCI-2014-01311 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IEO-833/13F
HHSN261201200034I
EIO 833/13F
2013-004862-32
TO-RFP A
N01-CN-2012-00034
IEO 833/13F (IEO37)
MDACC: 2013-0732
IEO 37
2013-0732 ( Other Identifier: M D Anderson Cancer Center )
MDA2013-01-01 ( Other Identifier: DCP )
N01CN00034 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: June 19, 2014
First Posted: June 23, 2014
Results First Submitted: December 20, 2019
Results First Posted: May 21, 2020
Last Update Posted: May 21, 2020