Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
This trial is active, not recruiting.
|Condition||patients at risk for melanoma|
|Treatments||n-acetylcysteine, placebo arm|
|Sponsor||University of Utah|
|Start date||September 2012|
|End date||August 2017|
|Trial size||141 participants|
|Trial identifier||NCT01612221, HCI50308|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator)|
Protection from UV-induced oxidative stress
time frame: 5 years
time frame: 5 years
Male or female participants at least 18 years old.
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.
|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|
|Principal investigator||Douglas Grossman, MD, PhD|
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