A Phase 3 randomized trial of nicotinamide for skin-cancer chemoprevention
Abstract
BACKGROUND: Nonmelanoma skin cancers, such as basal-cell carcinoma and squamous-cell carcinoma, are common cancers that are caused principally by ultraviolet (UV) radiation. Nicotinamide (vitamin B3) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses. METHODS: In this phase 3, double-blind, randomized, controlled trial, we randomly assigned, in a 1:1 ratio, 386 participants who had had at least two nonmelanoma skin cancers in the previous 5 years to receive 500 mg of nicotinamide twice daily or placebo for 12 months. Participants were evaluated by dermatologists at 3-month intervals for 18 months. The primary end point was the number of new nonmelanoma skin cancers (i.e., basal-cell carcinomas plus squamous-cell carcinomas) during the 12-month intervention period. Secondary end points included the number of new squamous-cell carcinomas and basal-cell carcinomas and the number of actinic keratoses during the 12-month intervention period, the number of nonmelanoma skin cancers in the 6-month postintervention period, and the safety of nicotinamide. RESULTS: At 12 months, the rate of new nonmelanoma skin cancers was lower by 23% (95% confidence interval [CI], 4 to 38) in the nicotinamide group than in the placebo group (P=0.02). Similar differences were found between the nicotinamide group and the placebo group with respect to new basal-cell carcinomas (20% [95% CI, -6 to 39] lower rate with nicotinamide, P=0.12) and new squamous-cell carcinomas (30% [95% CI, 0 to 51] lower rate, P=0.05). The number of actinic keratoses was 11% lower in the nicotinamide group than in the placebo group at 3 months (P=0.01), 14% lower at 6 months (P<0.001), 20% lower at 9 months (P<0.001), and 13% lower at 12 months (P=0.001). No noteworthy between-group differences were found with respect to the number or types of adverse events during the 12-month intervention period, and there was no evidence of benefit after nicotinamide was discontinued. CONCLUSIONS: Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients. (Funded by the National Health and Medical Research Council; ONTRAC Australian New Zealand Clinical Trials Registry number, ACTRN12612000625875.).
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Clinical data show NAM is relatively safe at 1,000-2,000 mg/day and is readily absorbed from the gastrointestinal tract, with peak serum concentrations 1 h after oral ingestion.
“the clinical data showing NAM is relatively safe (1,000–2,000 mg/day) and is readily absorbed from the gastrointestinal tract with peak serum concentrations in 1 h after oral ingestion”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
In some cases, NAD+/NADH and its metabolites can inhibit cancer growth and metastasis.
“in some cases NAD+/NADH and its metabolites can inhibit cancer growth and metastasis”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
A phase-III randomized large clinical trial reported that oral NAM was safe and effective in reducing new nonmelanoma skin cancers and actinic keratosis in high-risk patients.
“A phase-III randomized large clinical trial reported that oral NAM was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratosis in high-risk patients”
From NAD+ in Brain Aging and Neurodegenerative Disorders (2019) · cites this paper as Chen et al., 2015
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“Nicotinamide has been widely used to treat diseases such as diabetes, schizophrenia, Alzheimer’s disease, psoriasis, obesity, and cancer (Aisen et al., 2008; Bagcchi, 2015; Chase et al., 1992; Chen et al., 2015; Gale, 2004; Knip et al., 2000; Siadat et al., 2013; Smythies, 1973).”
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“In two clinical trials, nicotinamide decreased the incidence of NMSC and AK (28, 50).”
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“…serum nicotinamide levels in patients with POAG (Kouassi Nzoughet et al., 2019), and a good safety profile of nicotinamide demonstrated in large clinical trials (Chen et al., 2015a; Knip et al., 2000), human clinical trials started evaluating nicotinamide oral supplementation in glaucoma patients.”
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“Chen et al. recently reported hat in 386 immunocompetent patients at high risk of havng skin cancer, nicotinamide, 500 mg twice daily, reduced ew NMSCs by 23% (p = 0.02), with 20% fewer basal cell arcinomas and 30% fewer SCCs, compared with placebo.”
BackgroundInfluentialUse of nicotinamide in dermatology
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“The 86 serious adverse event reports, were evenly distributed across the placebo and NAM arms, with no notable between-group differences in adverse events nor in blood pressure or bodyweight (measured quarterly for 12 months), full blood count, renal function, or hepatic function (measured at baseline and at 12 months…”
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“In addition, nicotinamide has been the subject of several successful phase II and phase III clinical trials targeting carcinoma and non-melanoma skin cancer (39, 40).”
BackgroundThe Potential of Natural Compounds in UV Protection Products
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“Due to all the above, it has been shown that nicotinamide is a promising agent for skin cancer prevention [142,143].”
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“Remarkably, these effects of NAM might explain its preventive role in the occurrence of nonmelanoma skin cancers known to be induced by UVR (Chen et al., 2015; Kim et al., 2015).”
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“of nicotinamide twice daily for 12 months compared to placebo.(48) The protective effects of nicotinamide in this trial were thought be mediated by minimising the damage from UV radiation.”
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- Authors
- Chen, A. C., Martin, A. J., Choy, B., Fernández-Peñas, P., Dalziell, R. A., McKenzie, C. A., Scolyer, R. A., Dhillon, H. M., Vardy, J. L., Kricker, A., St. George, G., Chinniah, N., Halliday, G. M., & Damian, D. L.
- Affiliations
- The University of Sydney (AU)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-10-22
- Volume
- 373
- Issue
- 17
- Pages
- 1618-1626
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1852538637
- Cited by
- 648
- References
- 38
- Citations by year
- 2026: 53 · 2025: 66 · 2024: 59 · 2023: 74 · 2022: 61 · 2021: 75 · 2020: 55 · 2019: 57 · 2018: 49 · 2017: 51 · 2016: 38 · 2015: 4 · 2013: 1
- FWCI
- 37.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Keywords
- nicotinamide, nicotinic acid, skin cancer chemoprevention, non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, actinic keratosis, ultraviolet radiation, UV-induced DNA damage, NADPH oxidase, NADPH oxidase inhibitors, adverse events, drug safety, recurrence prevention, long-term follow-up
- MeSH terms
- Adult, Aged, Aged, 80 and over, Basal Cell Carcinoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Double-Blind Method, Female, Humans, Male, Middle Aged, Niacinamide, Skin Neoplasms, Vitamin B Complex, Secondary Prevention, Keratosis, Actinic
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