Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Treatments

Drug: Aspirin 325mg

Drug: Aspirin 81 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04062032

HCI94424 Pilot

Details and patient eligibility

About

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.

Full description

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
Must be older than age 18.
Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion criteria

The patient is a minor, under age 18.
The patient cannot speak / understand English or Spanish.
The patient is pregnant or breastfeeding.
The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
The patient has history of allergic reaction to ASA.
The patient has history of severe asthma.
The patient has been taking ASA or any NSAID in the past 2 weeks.
The patient has been taking a blood thinner in the past 2 weeks.
The patient has history of bleeding disorder.
The patient has history of peptic ulcer disease.
The patient has had recent intense UV exposure in the past month.