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

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aspirin 81 mg

Aspirin 325mg

Placebo oral tablet

About this trial

This is an interventional prevention trial for Melanoma (Skin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Huntsman Cancer Institute/University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ASA 81 mg daily

ASA 325 mg daily

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

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 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 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 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.

Full Information

NCT ID

NCT04066725

First Posted

August 21, 2019

Last Updated

February 16, 2022

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT04066725

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

July 25, 2019 (Actual)

Primary Completion Date

March 19, 2021 (Actual)

Study Completion Date

March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASA 81 mg daily

Arm Type

Experimental

Arm Description

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

Arm Title

ASA 325 mg daily

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin 81 mg

Other Intervention Name(s)

ASA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin 325mg

Other Intervention Name(s)

ASA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in minimal erythemal dose (MED) from baseline to day 60.

Description

Time Frame

Change from baseline to day 60

Title

Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60.

Description

Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.

Time Frame

Change from baseline to day 60

Title

Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60.

Description

Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.

Time Frame

Change from baseline to day 60

Secondary Outcome Measure Information:

Title

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

Description

Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.

Time Frame

Change from baseline to day 60

Title

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

Description

Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.

Time Frame

Change from baseline to day 60

Title

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

Description

Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.

Time Frame

Change from baseline to day 60

Title

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

Description

Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.

Time Frame

Change from baseline to day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas Grossman, MD

Organizational Affiliation

Huntsman Cancer Institute/ University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huntsman Cancer Institute/University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

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

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