Actively Recruiting
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Led by Women's College Hospital · Updated on 2025-02-21
396
Participants Needed
7
Research Sites
204 weeks
Total Duration
On this page
Sponsors
W
Women's College Hospital
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 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
You will not qualify if you...
- Use of nicotinamide or niacin (65250 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
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Not Yet Recruiting
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
3
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
4
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Actively Recruiting
6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
7
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Actively Recruiting
Research Team
S
Stephanie Jewell, BSc. Hons
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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