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

Completed · Phase 2 · Has a placebo group

Conditions studied: Patients at Risk for Melanoma

In brief

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.

Key facts

Study ID

NCT01612221

Run by

University of Utah

People needed

100

Starts

2012-09-01

Expected to finish

2016-02-01

Last updated by the study team

2017-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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