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

This study is currently recruiting participants.
Verified January 2014 by University of Utah
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01612221
First received: May 31, 2012
Last updated: January 23, 2014
Last verified: January 2014
  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

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: January 23, 2014
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 April 16, 2014