This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.
Primary Objectives I. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide. II. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi. Secondary Objectives I. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi. II. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma. III. Determine whether ASA affects inflammatory cytokines in plasma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
41
ASA 81mg taken daily
ASA 325mg taken daily
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
Concentration (ng/mL) of pre-treatment ASA metabolites (salicylate and salicylurate) in plasma will be compared to the concentration of ASA metabolites at day 7
Time frame: Change from baseline to day 7
Change in concentration of ASA metabolites in nevus tissue after ASA ingestion
Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7
Time frame: Change from baseline to day 7
Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.
Time frame: Change from baseline to day 7
Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.
Time frame: Change from baseline to day 7
Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
Quantitative densitometry analysis using Western blots will be performed on tissue collected at baseline and at day 7 to compare activation of AMP-activated protein kinase (AMPK).
Time frame: Change from baseline to day 7
Change in concentration of leukocytes in peripheral blood after ASA ingestion
Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes
Time frame: Change from baseline to day 7
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