Randomised double blinded placebo controlled trial to assess the effect of oral nicotinamide on numbers of new nonmelanoma skin cancers in immune competent adult patients with a history of at least two histologically confirmed nonmelanoma skin cancers within the previous five years

niversity of Sydney0 个研究点目标入组 386 人开始时间: 2012年6月12日最近更新: 2020年1月13日

适应症

试验速览

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•Aged 18 years or older with at least two histologically confirmed nonmelanoma skin cancers with the previous 5 years
•Equivalent to Year 8 spoken and written English skills to participate in the cognitive component of the study.

•1.Immune suppression (due to current immune suppressive medication, or immune suppressive medical condition such as haematological malignancy, HIV infection, congenital immune deficiency)
•2.Severe liver disease (transaminases >3x normal)
•3.Active peptic ulcer disease
•4.Recent myocardial infarction
•5.Hypotension
•6.Renal impairment with eGFR < 30 mL/min/1.73 m2
•7.Internal malignancy, metastatic SCC or invasive melanoma within the past 5 years.
•8.Need for ongoing carbamazepine use (possible interaction with nicotinamide).
•9.Patients unavailable for follow up for the duration of the study because of general frailty, geographical or social reasons.
•10.Gorlin’s syndrome or other genetic skin cancer syndrome.
•11.Huge numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers.
•12.Pregnancy or lactation (any women of childbearing potential will be required to use contraception throughout the study).
•13.Patients taking acitretin or other oral retinoids within the past 6 months
•14.Taking supplemental nicotinamide or niacin (other nicotinamide supplements to be ceased 4 weeks prior to study commencement).
•15.Field treatment for AKs (topical use of 5 fluorouracil, imiquimod, diclofenac, retinoids; topical photodynamic therapy for AKs; laser resurfacing or chemical peel treatments for AKs) within the previous 4 weeks.

发起方