Randomised double blinded placebo controlled trial to assess the effect of oral nicotinamide on numbers of new nonmelanoma skin cancers in immune suppressed adult renal transplant recipients with a history of at least two histologically confirmed nonmelanoma skin cancers within the previous 12 months

niversity of Sydney0 个研究点目标入组 80 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

暂无简介。

•1. Prior renal transplant performed more than 12 months ago.
•2. Current immune suppression.
•3. Past history of at least two histologically confirmed nonmelanoma skin cancers within the past 12 months.
•Equivalent to year 8 spoken and written English skills are required to participate in the cognitive component of the study. Patients with inadequate English skills may still participate in the other aspects of the study.

•1. Recent transplant less than 12 months ago.
•2. Unstable renal function.
•3. Treatment for acute rejection in the past 3 months.
•4. Significant liver disease (transaminases >3x normal), severe cardiac disease
•5. Internal malignancy, metastatic SCC or invasive melanoma within the past 5 years.
•6. Need for ongoing carbamazepine use (possible interaction with nicotinamide).
•7. Patients unavailable for follow up for the duration of the study because of general frailty, geographical or social reasons.
•8. Gorlin’s syndrome or other genetic skin cancer syndrome.
•9. Huge numbers of current skin cancers or large areas of confluent skin cancer at baseline preventing accurate assessment and counting of new skin cancers; field treatment for AKs within the past 4 weeks, preventing accurate assessment of AKs.
•10. Pregnancy or lactation (any women of childbearing potential will be required to use contraception throughout the study).
•11. Patients commenced on acitretin or other oral retinoids, or mTOR inhibitors within the past 6 months;
•12. Patients taking supplemental nicotinamide within the past 4 weeks.

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