Effect of oral nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence and actinic keratoses in renal transplant recipients: a randomised controlled trial

Phase 2

Completed

• Conditions: Basal cell carcinoma; Actinic keratoses; onmelanoma skin cancer; Cutaneous squamous cell carcinoma; Cognitive function; Kidney function after transplant; Nonmelanoma skin cancer; Cancer - Non melanoma skin cancer; Neurological - Studies of the normal brain and nervous system; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12612000628842
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified