Back to resultsOral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Primary Purpose
Patients at Risk for Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo arm
Sponsored by
About this trial
This is an interventional prevention trial for Patients at Risk for Melanoma
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.
Sites / Locations
- Huntsman Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Patients receiving N-acetylcysteine
Placebo Group
Arm Description
Patients receiving NAC (N-acetylcysteine)
Participants not receiving NAC (N-acetylcysteine)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01612221
Brief Title
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients at Risk for Melanoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving N-acetylcysteine
Arm Type
Experimental
Arm Description
Patients receiving NAC (N-acetylcysteine)
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants not receiving NAC (N-acetylcysteine)
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
N-acetylcysteine (NAC), 1200 mg Oral route 2 doses
Intervention Type
Other
Intervention Name(s)
Placebo arm
Intervention Description
Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
Primary Outcome Measure Information:
Title
UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
Description
Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Transcriptional Markers of UV-induced Oxidative Stress in Nevi
Description
Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi
Time Frame
3.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Grossman, MD, PhD
Organizational Affiliation
Huntsman Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
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