Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2016 |
| Start Date: | September 2012 |
| End Date: | February 2016 |
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
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.
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.
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.
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