Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial

Official Title

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial

Summary:

A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.

Trial Description

Primary Outcome:

• Feasibility (pertaining to patient recruitment)
• Feasibility (pertaining to appropriateness of eligibility criteria)
• Feasibility (pertaining to adherence to intervention)
• Feasibility (pertaining to adherence to follow-up assessments)
• Feasibility (pertaining to data linkage)
• Preliminary pooled keratinocyte carcinoma event rate
• Drug interactions
• Drug interactions
• Serious adverse events

• Feasibility of recruiting for neurocognitive substudy
• Baseline prevalence of cognitive impairment (substudy)
• Pooled standard deviation of MoCA test scores (substudy)
• Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)
• Pooled standard deviation of Trail Making A and B test scores (substudy)
• Pooled standard deviation of Controlled Oral Word Association test scores (substudy)
• Pooled standard deviation of Animal Naming Task scores (substudy)
• Pooled standard deviation of cognitive test scores (substudy)
• Pooled standard deviation of serum phosphate levels (substudy)

View this trial on ClinicalTrials.gov