Clinical trial NCT04062032: Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
Official title: Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
timeFrame: Change from baseline to day 7
measure: Change in concentration of ASA metabolites in nevus tissue after ASA ingestion
timeFrame: Change from baseline to day 7
measure: Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion
timeFrame: Change from baseline to day 7
measure: Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion
timeFrame: Change from baseline to day 7
Secondary outcomes:
measure: Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
timeFrame: Change from baseline to day 7
measure: Change in concentration of leukocytes in peripheral blood after ASA ingestion
timeFrame: Change from baseline to day 7
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Douglas Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References: