Phase 2
N=100
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Patients at Risk for Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01612221 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi — 94.6; 96.2; 33.6; 33.1 percentage of 8-OG expression in nevi — p=.65
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Placebo arm (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi |
94.6; 96.2; 33.6; 33.1 | .65 |
| SECONDARY Transcriptional Markers of UV-induced Oxidative Stress in Nevi |
8.99; 9.14; 9.29; 9.40; 8.73; 9.03 | 0.76 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01612221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.