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Completed

NCT Number: NCT01612221

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

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.

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Key information

Conditions

Patients at Risk for Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Other names: NAC

Placebo arm

Other

Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 5, 2012
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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