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

Patients at Risk for Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612221
• Other study ID #: HCI50308
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2012
• Last updated: December 1, 2016
• Start date: September 2012
• Est. completion date: February 2016

Study information

• Verified date: December 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Patients at Risk for Melanoma

Intervention

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

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

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protection from UV-induced oxidative stress	Test whether NAC (N-acetylcysteine) can protect nevi from UV-induced oxidative stress	5 years	No
Secondary	Determine biomarkers	Determine key biomarkers of susceptibility to UV-induced damage and protection by NAC (N-acetylcysteine)	5 years	No