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

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ClinicalTrials.gov Identifier: NCT01612221
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Patients at Risk for Melanoma
Interventions Drug: N-acetylcysteine
Other: Placebo arm
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Receiving N-acetylcysteine Placebo Group
Hide Arm/Group Description

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Patients Receiving N-acetylcysteine Placebo Group Total
Hide Arm/Group Description

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
  94.0%
46
  92.0%
93
  93.0%
>=65 years
3
   6.0%
4
   8.0%
7
   7.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
22
  44.0%
17
  34.0%
39
  39.0%
Male
28
  56.0%
33
  66.0%
61
  61.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
50
 100.0%
50
 100.0%
100
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50
 100.0%
50
 100.0%
100
 100.0%
1.Primary Outcome
Title UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
Hide Description Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.
Time Frame 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.
Arm/Group Title Patients Receiving N-acetylcysteine Placebo Group
Hide Arm/Group Description:

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: percentage of 8-OG expression in nevi
UV Irradiated 94.6  (12.3) 96.2  (7.5)
Unirradiated 33.6  (25.1) 33.1  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Receiving N-acetylcysteine, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Transcriptional Markers of UV-induced Oxidative Stress in Nevi
Time Frame 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.
Arm/Group Title Patients Receiving N-acetylcysteine Placebo Group
Hide Arm/Group Description:

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

Overall Number of Participants Analyzed 49 50
Mean (Standard Deviation)
Unit of Measure: markers of UV-induced oxidative stress
GCLM Biomarker 8.99  (.83) 9.14  (.75)
SLC1A4 Biomarker 9.29  (.87) 9.40  (1.06)
SLC7A11 Biomarker 8.73  (1.13) 9.03  (.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Receiving N-acetylcysteine, Placebo Group
Comments GCLM Biomarker analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients Receiving N-acetylcysteine, Placebo Group
Comments SLC1A4 Biomarker analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Patients Receiving N-acetylcysteine, Placebo Group
Comments SLC7A11 Biomarker analysis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Receiving N-acetylcysteine Placebo Group
Hide Arm/Group Description

Patients receiving NAC (N-acetylcysteine)

N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses

Participants not receiving NAC (N-acetylcysteine)

Placebo arm: Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose.

Then repeated 24 hours later.

All-Cause Mortality
Patients Receiving N-acetylcysteine Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Receiving N-acetylcysteine Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Receiving N-acetylcysteine Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kimberlee Taylor
Organization: Huntsman Cancer Institute
Phone: 801-213-5673
EMail: Kimberlee.Taylor@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01612221     History of Changes
Other Study ID Numbers: HCI50308
First Submitted: May 31, 2012
First Posted: June 5, 2012
Results First Submitted: March 7, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017