Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA 81 mg daily | Experimental | Participants will be given ASA 81 mg orally once daily for a total of 60 days |
|
| ASA 325 mg daily | Experimental | Participants will be given ASA 325 mg orally once daily for a total of 60 days. |
|
| Placebo | Placebo Comparator | Participants will be given a placebo orally once daily for a total of 60 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | Participants will be given ASA 81 mg orally once daily for a total of 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in minimal erythemal dose (MED) 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). | Change from baseline to day 60 |
| Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60. | Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60. | Change from baseline to day 60 |
| Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60. | Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60. | Change from baseline to day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60. | Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60. | Change from baseline to day 60 |
| Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Grossman, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aspirin 325mg | Drug | Participants will be given ASA 325 mg orally once daily for a total of 60 days |
|
|
| Placebo oral tablet | Drug | Participants will be given placebo orally once daily for a total of 60 days |
|
Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60. |
| Change from baseline to day 60 |
| Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in nevus tissue from baseline to day 60. | Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60. | Change from baseline to day 60 |
| Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60. | Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60. | Change from baseline to day 60 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |