Skin cancer is four times as common in Australia as all other cancers combined, and its incidence continues to increase. Nontoxic, affordable chemopreventive agents are urgently needed to reduce skin cancer rates, especially in high risk groups. Nicotinamide (vitamin B3) is inexpensive, widely available and non-toxic. It inhibits phocarcinogenesis in murine models and mice and protects from ultraviolet radiation-induced immunosuppression in humans. Phase 2 studies have shown significant reductions in AKs and nonmelanoma skin cancer in sun-damaged volunteers. Nicotinamide seems to act by replenishes cellular energy and enhances repair of photodamaged DNA.
A Phase 3 randomised double blinded controlled trial is currently underway to determine whether oral nicotinamide can reduce basal cell and squamous cell cancers in individuals at high skin cancer risk. The ONTRAC study (Oral Nicotinamide To Reduce Actinic Cancer) is underway at Sydney’s Royal Prince Alfred and Westmead Hospitals. 386 high-risk patients are randomised 1:1 to nicotinamide 500mg or placebo twice daily for 12 months with skin checks every 3 months. The primary outcome is new nonmelanoma skin cancers by 12 months.
This study aims to evaluate the efficacy of nicotinamide as a safe, inexpensive, accessible and convenient chemopreventive agent against NMSC that is instantly translatable to clinical practice.