Effect of oral nicotinamide (vitamin B3) on skin cancer incidence and actinic keratoses in kidney, liver, heart and lung transplant recipients: a randomised controlled Phase 3 trial

Phase 3

• Conditions: non-melanoma skin cancer; basal cell carcinoma; cutaneous squamous cell carcinoma; actinic keratoses; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12617000599370
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-27
• Study Completion: 2020-09-30
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified