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

This study has been completed.
Information provided by (Responsible Party):
University of Utah Identifier:
First received: May 31, 2012
Last updated: June 29, 2017
Last verified: June 2017
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 Intervention Phase
Patients at Risk for Melanoma Drug: N-acetylcysteine Other: Placebo arm Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 100
Study Start Date: September 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: University of Utah Identifier: NCT01612221     History of Changes
Other Study ID Numbers: HCI50308
Study First Received: May 31, 2012
Results First Received: March 7, 2017
Last Updated: June 29, 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
Antidotes processed this record on September 21, 2017