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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066725
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : July 25, 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Aspirin

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Change in minimal erythemal dose (MED) from baseline to day 60. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Change from baseline to day 60 ]
    Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066725


Contacts
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Contact: Douglas Grossman, MD 801-581-4682 doug.grossman@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Douglas Grossman, MD    801-581-4682    doug.grossman@hci.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Douglas Grossman, MD Huntsman Cancer Institute/ University of Utah
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04066725    
Other Study ID Numbers: HCI94424
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics