Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Recruiting · NCT05955924 · Interventional (participants receive a specific treatment) · Lead sponsor: Women's College Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years old
- Kidney, liver, heart, or lung transplant at least two years ago
- History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
- Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
- Able to attend follow-up visits
Exclusion criteria
- Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks
- Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)
- Biopsy-confirmed acute rejection episode within the past 12 weeks
- Active liver disease (high AST \>3 times or bilirubin \>1.5 times)
- Severe kidney disease (estimated glomerular filtration rate \<20 mL/min/1.73 m2)
- Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years
- Pregnancy or lactation
- Need for ongoing carbamazepine or primidone
- Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules
Where it is running
7 locations listed.
- University of Calgary - Calgary, Alberta, Canada
- University of Alberta - Edmonton, Alberta, Canada
- Vancouver General Hospital - Vancouver, British Columbia, Canada
- St. Paul's Hospital - Vancouver, British Columbia, Canada
- The Ottawa Hospital - Ottawa, Ontario, Canada
- Toronto General Hospital - Toronto, Ontario, Canada
- Women's College Hospital - Toronto, Ontario, Canada