Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
NCT Number: NCT04066725
This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Salt Lake City, Utah, 84112, United States
While melanoma risk is largely genetically determined, exposure to ultraviolet (UV) radiation in sunlight is the major environmental risk factor. Although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly.
This study will evaluate the downstream effects of aspirin (ASA) in human blood and skin moles (nevi) following oral ingestion. We will determine if chronic ingestion of ASA can modulate UV-sensitivity of the skin, UV-induced damage in nevi, and PGE2 levels in blood and nevi.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be given ASA 81 mg orally once daily for a total of 60 days
Other names: ASA
Participants will be given ASA 325 mg orally once daily for a total of 60 days
Other names: ASA
Participants will be given placebo orally once daily for a total of 60 days
Time frame: Change from baseline to day 60
Baseline minimal erythemal dose (MED) measurements will will be compared to MED results at day 60. We will use the conventional definition of MED as the lowest UV dose resulting in erythema that completely fills the 8-mm irradiated site (homogeneous erythema).
Time frame: Change from baseline to day 60
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.
Time frame: Change from baseline to day 60
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.
Time frame: Change from baseline to day 60
Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.
Time frame: Change from baseline to day 60
Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.
Time frame: Change from baseline to day 60
Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.
Time frame: Change from baseline to day 60
Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.
University of Utah
Other
A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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