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

Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Drug: Aspirin 81 mg; Drug: Aspirin 325mg

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ASA 81 mg daily; Participants will be given ASA 81 mg orally once daily for a total of 7 days	Drug: Aspirin 81 mg; ASA 81mg taken daily; Other Names: ASA
EXPERIMENTAL: ASA 325 mg daily; Participants will be given ASA 325 mg orally once daily for a total of 7 days.	Drug: Aspirin 325mg; ASA 325mg taken daily; Other Names: ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	Change from baseline to day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	Change from baseline to day 7

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Douglas Grossman, MD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2016
• Primary Completion (ACTUAL): February 27, 2019
• Study Completion (ACTUAL): February 27, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 18, 2019
• First Posted (ACTUAL): August 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: HCI94424 Pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No