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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving N-acetylcysteine | Experimental | Patients receiving NAC (N-acetylcysteine) |
|
| Placebo Group | Placebo Comparator | Participants not receiving NAC (N-acetylcysteine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | N-acetylcysteine (NAC), 1200 mg Oral route 2 doses |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Grossman, MD, PhD | Huntsman Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving N-acetylcysteine | Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses |
| FG001 | Placebo Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving N-acetylcysteine | Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses |
| BG001 | Placebo Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of 8-OG expression in nevi | 3.5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving N-acetylcysteine | Patients receiving NAC (N-acetylcysteine) N-acetylcysteine: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberlee Taylor | Huntsman Cancer Institute | 801-213-5673 | Kimberlee.Taylor@hci.utah.edu |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo arm | Other | Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Placebo Group |
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. |
|
|
|
| Secondary | 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 | One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi. | Posted | Mean | Standard Deviation | markers of UV-induced oxidative stress | 3.5 years |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Placebo Group | 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. | 0 | 50 | 0 | 50 | 0 | 50 |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| SLC7A11 Biomarker |
|
| 0.63 |
| Superiority |
| SLC7A11 Biomarker analysis. | ANCOVA | 0.27 | Superiority |