Effect of oral nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence and actinic keratoses in renal transplant recipients: a randomised controlled trial
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
University of Sydney
80 participants
Aug 9, 2012
Interventional
Conditions
Summary
This study aims to assess the effect of nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence in renal transplant recipients. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had a renal transplant more than 12 months ago. You should be experiencing current immune suppression and have a past history of at least two confirmed nonmelanoma skin cancers within the past 12 months. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 6 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancers and the safety of this treatment in renal transplant recipients.
Eligibility
Inclusion Criteria4
- Prior renal transplant performed more than 12 months ago.
- Current immune suppression.
- 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.
Exclusion Criteria12
- Recent transplant less than 12 months ago.
- Unstable renal function.
- Treatment for acute rejection in the past 3 months.
- Significant liver disease (transaminases >3x normal), severe cardiac disease
- Internal malignancy, metastatic SCC or invasive melanoma within the past 5 years.
- Need for ongoing carbamazepine use (possible interaction with nicotinamide).
- Patients unavailable for follow up for the duration of the study because of general frailty, geographical or social reasons.
- Gorlin’s syndrome or other genetic skin cancer syndrome.
- 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.
- Pregnancy or lactation (any women of childbearing potential will be required to use contraception throughout the study).
- Patients commenced on acitretin or other oral retinoids, or mTOR inhibitors within the past 6 months;
- Patients taking supplemental nicotinamide within the past 4 weeks.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Oral nicotinamide 500mg orally or placebo twice daily for 6 months
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000628842