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

NCT ID: NCT01612221

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Patients receiving N-acetylcysteine

Patients receiving NAC (N-acetylcysteine)

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

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

Placebo Group

Participants not receiving NAC (N-acetylcysteine)

Group Type: PLACEBO_COMPARATOR

Placebo arm

Intervention Type: OTHER

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

Interventions

N-acetylcysteine

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

Intervention Type: DRUG

Placebo arm

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

Intervention Type: OTHER

Other Intervention Names

NAC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Grossman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HCI50308

Identifier Type: -

Identifier Source: org_study_id