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

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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

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE August 26, 2019
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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).
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma
Official Title  ICMJE A Phase II Placebo-controlled Intervention Trial of Oral Aspirin (ASA) as a UV Protectant in Vivo
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Drug: Aspirin 81 mg
    Participants will be given ASA 81 mg orally once daily for a total of 60 days
    Other Name: ASA
  • Drug: Aspirin 325mg
    Participants will be given ASA 325 mg orally once daily for a total of 60 days
    Other Name: ASA
  • Drug: Placebo oral tablet
    Participants will be given placebo orally once daily for a total of 60 days
Study Arms  ICMJE
  • Experimental: ASA 81 mg daily
    Participants will be given ASA 81 mg orally once daily for a total of 60 days
    Intervention: Drug: Aspirin 81 mg
  • Experimental: ASA 325 mg daily
    Participants will be given ASA 325 mg orally once daily for a total of 60 days.
    Intervention: Drug: Aspirin 325mg
  • Placebo Comparator: Placebo
    Participants will be given a placebo orally once daily for a total of 60 days.
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2027
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Douglas Grossman, MD 801-581-4682 doug.grossman@hci.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04066725
Other Study ID Numbers  ICMJE HCI94424
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Grossman, MD Huntsman Cancer Institute/ University of Utah
PRS Account University of Utah
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP