None listed
Conditions
Brief summary
This study aims to assess the effect of nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence in renal, hepatic, heart and lung 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 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 5 years. 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 12 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 transplant recipients.
Interventions
Oral nicotinamide 500mg or placebo twice daily for 12 months. Adherence to intervention monitored by drug tablet return.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Prior renal, hapatic, heart or lung transplant performed more than 12 months ago 2. At least two histologically confirmed nonmelanoma skin cancers within the past 5 years
Exclusion criteria
1. Unstable renal or liver function 2. Acute rejection within the past 3 months 3. Immune suppression due to noniatrogenic causes (eg haematological malignancy, HIV) 4. Severe liver function abnormality (transaminases >3x normal; bilirubin >1.5x normal) 5. Active peptic ulcer disease 6. Myocardial infarction within the past 6 months 7. Hypotension (systolic BP < 90 mmHg) 8. Renal impairment with eGFR < 20 mL/min/1.73 m2 9. Internal malignancy, metastatic SCC or invasive melanoma or Merkel cell carcinoma within the past five years 10. Need for ongoing carbamazepine use (possible interaction with nicotinamide) 11. Patient unavailable for follow-up for the duration of the study because of general frailty, geographical, social or other reasons 12. Gorlin’s syndrome or other genetic skin cancer syndrome 13. Large areas of confluent skin cancer (> 20 cm diameter) at baseline preventing accurate assessment and counting of new skin cancers 14. Pregnancy or lactation 15. Patients commencing acitretin or other oral retinoids within the past 6 months (patients taking acitretin for six months or longer are eligible for randomisation) 16. Patients commencing mTor inhibitors within the past 6 months (patients taking mTor inhibitors for six months or longer are eligible for randomisation) 17. Supplemental nicotinamide or niacin (as part of a multivitamin preparation) at doses greater than 20mg daily within the past 4 weeks. 18. Taking pharmacological doses of nicotinamide (equal to or greater than 500mg daily) (nicotinamide to be ceased 3 months prior to study commencement). 19. Field treatment for actinic keratoses (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. Field treatments for AKs are permitted in the second half of the intervention period (ie after the 6 month visit) if considered medically necessary.
Outcome results
None listed