Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
This study is currently recruiting participants.
Verified April 2013 by University of Utah
Sponsor:
University of Utah
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01612221
First received: May 31, 2012
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients at Risk for Melanoma |
Drug: N-acetylcysteine Other: Placebo arm |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Protection from UV-induced oxidative stress [ Time Frame: 5 years ] [ Designated as safety issue: No ]Test whether NAC (N-acetylcysteine) can protect nevi from UV-induced oxidative stress
Secondary Outcome Measures:
- Determine biomarkers [ Time Frame: 5 years ] [ Designated as safety issue: No ]Determine key biomarkers of susceptibility to UV-induced damage and protection by NAC (N-acetylcysteine)
| Estimated Enrollment: | 218 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patients receiving N-acetylcysteine
Patients receiving NAC (N-acetylcysteine)
|
Drug: N-acetylcysteine
N-acetylcysteine (NAC), 1200 mg Oral route 2 doses
Other Name: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612221
Contacts
| Contact: Darren Walker | 801-587-4323 | darren.walker@hci.utah.edu |
| Contact: Candace Larson | 801-213-4241 | candace.larson@hci.utah.edu |
Locations
| United States, Utah | |
| Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Principal Investigator: Douglas Grossman, MD, PhD | |
| Sub-Investigator: Scott Florell, MD | |
| Sub-Investigator: Pamela Cassidy, PhD | |
Sponsors and Collaborators
University of Utah
Investigators
| Principal Investigator: | Douglas Grossman, MD, PhD | Huntsman Cancer Institute |
More Information
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT01612221 History of Changes |
| Other Study ID Numbers: | HCI50308 |
| Study First Received: | May 31, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Nevi and Melanomas Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Acetylcysteine N-monoacetylcystine Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |
ClinicalTrials.gov processed this record on June 18, 2013