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Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT04062032
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
29
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aspirin 81 mg
  • Drug: Aspirin 325mg
 Phase 2

Detailed Description

Primary Objectives

  1. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide.

  2. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi.

Secondary Objectives

  1. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.

  2. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.

  3. Determine whether ASA affects inflammatory cytokines in plasma.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
Actual Study Start Date :
Sep 27, 2016
Actual Primary Completion Date :
Feb 27, 2019
Actual Study Completion Date :
Feb 27, 2019

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 7 days

Drug: Aspirin 81 mg
ASA 81mg taken daily
Other Names:
  • ASA

    		•
    Experimental: ASA 325 mg daily

    Participants will be given ASA 325 mg orally once daily for a total of 7 days.

    Drug: Aspirin 325mg
    ASA 325mg taken daily
    Other Names:
  • ASA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion [Change from baseline to day 7]

      Concentration (ng/mL) of pre-treatment ASA metabolites (salicylate and salicylurate) in plasma will be compared to the concentration of ASA metabolites at day 7

    2. Change in concentration of ASA metabolites in nevus tissue after ASA ingestion [Change from baseline to day 7]

      Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7

    3. Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion [Change from baseline to day 7]

      Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.

    4. Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion [Change from baseline to day 7]

      Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.

    Secondary Outcome Measures

    1. Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion [Change from baseline to day 7]

      Quantitative densitometry analysis using Western blots will be performed on tissue collected at baseline and at day 7 to compare activation of AMP-activated protein kinase (AMPK).

    2. Change in concentration of leukocytes in peripheral blood after ASA ingestion [Change from baseline to day 7]

      Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 is a minor, under age 18.

    • 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:
    NCT04062032
    Other Study ID Numbers:
    • HCI94424 Pilot
    First Posted:
    Aug 20, 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