Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma

A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo

This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• 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: No
• 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 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: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

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 60 days	Drug: Aspirin 81 mg; Participants will be given ASA 81 mg orally once daily for a total of 60 days; Other Names: ASA
EXPERIMENTAL: ASA 325 mg daily; Participants will be given ASA 325 mg orally once daily for a total of 60 days.	Drug: Aspirin 325mg; Participants will be given ASA 325 mg orally once daily for a total of 60 days; Other Names: ASA
PLACEBO_COMPARATOR: Placebo; Participants will be given a placebo orally once daily for a total of 60 days.	Drug: Placebo oral tablet; Participants will be given placebo orally once daily for a total of 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

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): July 25, 2019
• Primary Completion (ACTUAL): March 19, 2021
• Study Completion (ACTUAL): March 19, 2021

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 26, 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

Drug and device information, study documents

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