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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Patients at Risk for Melanoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Protection from UV-induced oxidative stress

Outcome Description:

Test whether NAC (N-acetylcysteine) can protect nevi from UV-induced oxidative stress

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Douglas Grossman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

HCI50308

NCT ID:

NCT01612221

Start Date:

September 2012

Completion Date:

October 2016

Related Keywords:

  • Patients at Risk for Melanoma
  • Melanoma

Name

Location

Huntsman Cancer Institute Salt Lake City, Utah  84112