Healthy volunteers
Conditions
Interventions
Trade Name: Trombyl
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: ACETYLSALICYLIC ACID
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Linköping University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Postmenopausal women defined as > 12 months since last menstruation •55-74 years of age •A baseline left breast density score of > 75% as measured by standard digital mammography (BIRADs score D) •A willingness to follow the study protocol, as indicated by provision of informed consent to participate •A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted) •Healthy without serious co-morbidity, according to the investigators decision •Normal renal function as determined by a serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: •Abnormal finding on MRI at screening •Any sex steroid containing systemic hormonal therapy including postmenopausal replacement therapy and hormonal IUD (intrauterine device) ongoing or within the last 3 months •Previously affected or treated breasts including irradiation and reductive surgery. Diagnostic and investigative punctures are allowed. •Current or anticipated need for daily NSAID use including ASA for cardiovascular protection •Known intolerance to NSAIDs •History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA) •Known contraindication to NSAID use •History of breast cancer including in situ disease •Diabetes requiring drug therapy •Current smoker •Uncontrolled hypertension •History of GI ulcers, chronic GERD (reflux disease), or GI bleeding in the past 5 years •History of a bleeding diathesis or current anticoagulant therapy •History of claustrophobia •MR contraindications according to the radiologist’s decision •Allergy to gadolinium contrast
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the in vivo extracellular levels of IL-6, IL-8, or CCL5 decrease in dense breast tissue in women treated with ASA compared to untreated controls. ;Secondary Objective: • To investigate whether LTF measured by MRI decrease in dense breast tissue in women treated with ASA compared to untreated controls. • To investigate whether the amount and type of inflammatory cells are affected in dense breast tissue in women treated with ASA compared to untreated controls. • To investigate whether other biological markers associated with breast carcinogenesis or inflammation such as the extracellular in vivo expression of panels of proteins, microRNAs and amino acids are affected in dense breast tissue in women treated with ASA compared to untreated controls. ;Primary end point(s): IL-6, IL-8 and CCL5 levels in breast extracellular fluids obatined by microdialysis and measured using immune based methods. ;Timepoint(s) of evaluation of this end point: Six months after treatment with ASA or no treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Breast density measured as Lean Tissue Fraction from magnetic resonance images * The amount and type of inflammatory cells in breast tissue biopsies. * Other biological markers associated with breast carcinogenesis or inflammation such as the extracellular in vivo expression of panels of proteins, microRNAs and amino acids.;Timepoint(s) of evaluation of this end point: Six months after treatment with ASA or no treatment. | — |
Countries
Sweden
Contacts
Public ContactCharlotta Dabrosin
Linköping University
Outcome results
None listed