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

Phase 2

Completed

• Conditions: Patients at Risk for Melanoma
• Interventions: Other: Placebo arm; Drug: N-acetylcysteine

• Registration Number: NCT01612221
• Lead Sponsor: University of Utah

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Study Start: 2012-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2017-03-07
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-29
• Last Update Submitted: 2017-06-29
• Results First Posted: 2017-07-31
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo arm	Participants not receiving NAC (N-acetylcysteine)
Patients receiving N-acetylcysteine	N-acetylcysteine	Patients receiving NAC (N-acetylcysteine)

Primary Outcome Measures

Name	Time	Method
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi	3.5 years	Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.

Secondary Outcome Measures

Name	Time	Method
Transcriptional Markers of UV-induced Oxidative Stress in Nevi	3.5 years	Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States