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

NCT ID: NCT04066725

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2021-03-19

Brief Summary

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

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ASA 81 mg daily

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

Group Type: EXPERIMENTAL

Aspirin 81 mg

Intervention Type: DRUG

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

ASA 325 mg daily

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

Group Type: EXPERIMENTAL

Aspirin 325mg

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

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

Interventions

Aspirin 81 mg

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

Intervention Type: DRUG

Aspirin 325mg

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

Intervention Type: DRUG

Placebo oral tablet

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

Intervention Type: DRUG

Other Intervention Names

ASA; ASA

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Locations

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HCI94424

Identifier Type: -

Identifier Source: org_study_id