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

NCT04066725 | Completed Phase 2 DMC

• 1 other identifier: HCI94424
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.

  Change from baseline to day 60

• Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to 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.

  Change from baseline to day 60

• Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.

  Change from baseline to day 60

Study Arms (3)

ASA 81 mg daily

EXPERIMENTAL

Participants will be given ASA 81 mg orally once daily for a total of 60 days

Drug: Aspirin 81 mg

ASA 325 mg daily

EXPERIMENTAL

Participants will be given ASA 325 mg orally once daily for a total of 60 days.

Drug: Aspirin 325mg

Placebo

PLACEBO COMPARATOR

Participants will be given a placebo orally once daily for a total of 60 days.

Drug: Placebo oral tablet

Interventions

Aspirin 81 mg DRUG

Participants will be given ASA 81 mg orally once daily for a total of 60 days

Also known as: ASA

ASA 81 mg daily

Aspirin 325mg DRUG

Participants will be given ASA 325 mg orally once daily for a total of 60 days

Also known as: ASA

ASA 325 mg daily

Placebo oral tablet DRUG

Participants will be given placebo orally once daily for a total of 60 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Douglas Grossman, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: July 25, 2019
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

US (1)