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

NCT01612221 | Completed Phase 2 Results DMC

• 1 other identifier: HCI50308
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients at Risk for Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Transcriptional Markers of UV-induced Oxidative Stress in Nevi

  3.5 years

Study Arms (2)

Patients receiving N-acetylcysteine

EXPERIMENTAL

Patients receiving NAC (N-acetylcysteine)

Drug: N-acetylcysteine

Placebo Group

PLACEBO COMPARATOR

Participants not receiving NAC (N-acetylcysteine)

Other: Placebo arm

Interventions

N-acetylcysteine DRUG

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

Also known as: NAC

Patients receiving N-acetylcysteine

Placebo arm OTHER

Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kimberlee Taylor
• Organization: Huntsman Cancer Institute

Kimberlee.Taylor@hci.utah.edu

801-213-5673

Study Officials

• Douglas Grossman, MD, PhD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-06

Locations

US (1)