Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Status:
Recruiting
Trial end date:
2027-08-01
Target enrollment:
Participant gender:
Summary
As patients live longer after receiving an organ transplant, there is a need to reduce the
long-term side effects of the drugs used to prevent organ rejection. In particular, long-term
use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of
illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the
increased risk and burden of skin cancer in transplant recipients, prevention is critical.
Nicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in
the general population. However, it is unclear whether nicotinamide is effective among
immune-suppressed transplant recipients. Investigators will conduct a clinical trial
involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg
twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396
high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at
least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years.
The results will inform efforts to improve the long-term health of transplant recipients.
Phase:
Phase 3
Details
Lead Sponsor:
Women's College Hospital
Collaborators:
Canadian Institutes of Health Research (CIHR) NOW Foods University Health Network, Toronto