This trial has been completed.

Condition patients at risk for melanoma
Treatments n-acetylcysteine, placebo arm
Phase phase 2
Sponsor University of Utah
Start date September 2012
End date February 2016
Trial size 151 participants
Trial identifier NCT01612221, HCI50308


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Patients receiving NAC (N-acetylcysteine)
n-acetylcysteine NAC
N-acetylcysteine (NAC), 1200 mg Oral route 2 doses
(Placebo Comparator)
Participants not receiving NAC (N-acetylcysteine)
placebo arm
Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.

Primary Outcomes

Protection from UV-induced oxidative stress
time frame: 5 years

Secondary Outcomes

Determine biomarkers
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Douglas Grossman, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Utah.