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

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT04066725
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 3
• Actual Duration (Months): 19.8
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Drug: Aspirin 81 mg; Drug: Aspirin 325mg; Drug: Placebo oral tablet	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
• Actual Study Start Date: Jul 25, 2019
• Actual Primary Completion Date: Mar 19, 2021
• Actual Study Completion Date: Mar 19, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

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

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Utah
• ClinicalTrials.gov Identifier: NCT04066725
• Other Study ID Numbers: HCI94424
• First Posted: Aug 26, 2019
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Melanoma; Aspirin

Study Results

No Results Posted as of Feb 18, 2022