Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

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. Read our disclaimer for details. Identifier: NCT01612221
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Information provided by (Responsible Party):
University of Utah

Brief Summary:
This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.

Condition or disease Intervention/treatment Phase
Patients at Risk for Melanoma Drug: N-acetylcysteine Other: Placebo arm Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Study Start Date : September 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles

Arm Intervention/treatment
Experimental: Patients receiving N-acetylcysteine
Patients receiving NAC (N-acetylcysteine)
Drug: N-acetylcysteine
N-acetylcysteine (NAC), 1200 mg Oral route 2 doses
Other Name: NAC

Placebo Comparator: Placebo Group
Participants not receiving NAC (N-acetylcysteine)
Other: Placebo arm
Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Primary Outcome Measures :
  1. UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi [ Time Frame: 3.5 years ]
    Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.

Secondary Outcome Measures :
  1. Transcriptional Markers of UV-induced Oxidative Stress in Nevi [ Time Frame: 3.5 years ]
    Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi

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:   Yes

Inclusion Criteria:

  • Must have at least 2 nevi (each >6 mm diameter) not clinically suspicious for melanoma that can be biopsied.
  • 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 (< 18 years old).
  • The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed)
  • The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.)
  • The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
  • The patient has history of allergic reaction to NAC.
  • The patient has history of severe asthma.
  • The patient has been taking NAC or any other oral antioxidant.
  • The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.

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 identifier (NCT number): NCT01612221

United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Principal Investigator: Douglas Grossman, MD, PhD Huntsman Cancer Institute

Responsible Party: University of Utah Identifier: NCT01612221     History of Changes
Other Study ID Numbers: HCI50308
First Posted: June 5, 2012    Key Record Dates
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs