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Nicotinamide for Skin-Cancer Chemoprevention in Transplant Recipients
Nicholas C Allen1, Andrew J Martin1, Victoria A Snaidr1
1From the Department of Dermatology, University of Sydney at Royal Prince Alfred Hospital (N.C.A., V.A.S., A.D.G., A.C.C., D.L.D.), the NHMRC (National Health and Medical Research Council) Clinical Trials Centre, University of Sydney (A.J.M., R.E.), and the Department of Renal Medicine (S.J.C.) and the A.W. Morrow Gastroenterology and Liver Centre (D.G.B.), Royal Prince Alfred Hospital, Camperdown, NSW, the Skin Health Institute, Carlton, VIC (A.H.C., K.J.A., R.B.D., B.P.M., T.K.), the Department of Dermatology, University of Sydney at Westmead Hospital, Westmead, NSW (P.F.-P.), the Department of Dermatology, the Alfred Hospital (D.G., A.D.G., J.N.), the Department of Anatomical Pathology, Alfred Health (C.M.), and the Department of Anatomical Pathology, Royal Melbourne Hospital (A. Landgren), Melbourne, VIC, the Department of Dermatology, Royal Adelaide Hospital (S.S., C.A., B.W., B.S.), and South Australia Pathology (J.I.), Adelaide, SA, the Department of Dermatology, University of New South Wales at St. Vincent's Hospital (V.L.P., N.D.R., T.S.), NSW Health Pathology (C.A.M., R.A.S.), the Department of Tissue Pathology and Diagnostic Oncology, Royal Prince Alfred Hospital (C.A.M., R.A.S.), Faculty of Medicine and Health (R.A.S., J.L.V., D.G.B.), Melanoma Institute Australia (R.A.S., D.L.D.), Charles Perkins Centre (R.A.S., S.J.C.), and the Centre for Medical Psychology and Evidence-Based Decision-Making (H.M.D., J.L.V.), University of Sydney, and the Liver Immunology Program, the Centenary Institute, University of Sydney and Royal Prince Alfred Hospital (D.G.B.), Sydney, the Departments of Dermatology (L.A.B., H.S., A.D., A.T., H.G., H.A.E.) and Pathology (A.D.), Sunshine Coast University Hospital, Griffith University Medical School (L.A.B.), and the School of Health and Behavioural Sciences, University of the Sunshine Coast (A.D.), Birtinya, QLD, the Department of Dermatology, University of Sydney at Royal North Shore Hospital, St. Leonards, NSW (A. Lim), the Department of Dermatology, Royal Melbourne Hospital, Parkville, VIC (E.U., B.J.D., Y.K., K.S., Z.M.L.), the Dermatology Research Centre, Diamantina Institute, the University of Queensland (H.S., H.A.E.), and the Department of Dermatology, Princess Alexandra Hospital (H.A.E.), Woolloongabba, QLD, Melbourne Pathology, Sonic Healthcare, Collingwood, VIC (S.P.), Southern.IML Pathology, Sonic Healthcare, Coniston, NSW (A. Lochhead), Wollongong Hospital, Wollongong, NSW (A. Lochhead), the School of Medicine, University of Queensland, Herston (A.T.), and the Department of Medicine, Concord Clinical School, University of Sydney, and Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW (J.L.V.) - all in Australia.
Oral nicotinamide (vitamin B3) did not prevent new skin cancers in organ transplant recipients. This study found no significant difference in keratinocyte cancers or actinic keratoses between patients taking nicotinamide or a placebo.
Area of Science:
- Oncology
- Dermatology
- Transplantation Medicine
Background:
- Organ-transplant recipients face higher skin cancer risks due to immunosuppression.
- Nicotinamide (vitamin B3) shows promise in DNA repair and reducing UV-induced immunosuppression in immunocompetent individuals.
- The efficacy of oral nicotinamide for skin cancer chemoprevention in transplant recipients remains uncertain.
Purpose of the Study:
- To evaluate the efficacy of oral nicotinamide in preventing keratinocyte cancers in immunosuppressed organ-transplant recipients.
- To assess the impact of nicotinamide on squamous-cell carcinomas, basal-cell carcinomas, and actinic keratoses.
- To determine the safety and quality-of-life effects of nicotinamide in this patient population.
Main Methods:
- A phase 3, randomized, placebo-controlled trial involving 158 organ-transplant recipients with a history of at least two keratinocyte cancers in the past 5 years.
- Participants received either 500 mg of nicotinamide or a placebo twice daily for 12 months.
- Primary endpoint: number of new keratinocyte cancers; secondary endpoints: counts of specific cancer types, actinic keratoses, safety, and quality of life.
Main Results:
- The trial was stopped early due to poor recruitment.
- No significant difference was observed in the number of new keratinocyte cancers between the nicotinamide group (207) and the placebo group (210) at 12 months (rate ratio, 1.0; P=0.96).
- No significant differences were found in squamous-cell carcinoma counts, basal-cell carcinoma counts, actinic keratosis counts, or quality-of-life scores between the groups. Adverse events were similar.
Conclusions:
- Oral nicotinamide therapy did not reduce the incidence of keratinocyte cancers or actinic keratoses in immunosuppressed solid-organ transplant recipients over a 12-month period.
- The findings suggest nicotinamide is not effective for skin cancer chemoprevention in this high-risk group.
- Further research may be needed to explore alternative chemopreventive strategies for organ-transplant recipients.
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