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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients at Risk for Melanoma
• Intervention / Treatment: Drug: N-acetylcysteine; Other: Placebo arm

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving N-acetylcysteine; Patients receiving NAC (N-acetylcysteine)	Drug: N-acetylcysteine; N-acetylcysteine (NAC), 1200 mg Oral route 2 doses; Other Names: NAC
Placebo Comparator: Placebo Group; Participants not receiving NAC (N-acetylcysteine)	Other: Placebo arm; Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Douglas Grossman, MD, PhD, Huntsman Cancer Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: HCI50308