Preventing skin cancer in organ transplant recipients using nicotinamide
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial
This study is testing if taking nicotinamide, a form of Vitamin B3, can help prevent skin cancer in organ transplant recipients who are at high risk.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 7 sites (Calgary, Alberta and 6 other locations) |
| Trial ID | NCT05955924 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of oral nicotinamide, a form of Vitamin B3, in preventing keratinocyte carcinoma among high-risk solid organ transplant recipients. The study will involve 396 adult patients who have previously had skin cancer and are currently on immunosuppressive therapy. Participants will receive either nicotinamide (500 mg twice daily) or a placebo for up to 208 weeks, alongside standard care. The trial aims to determine if nicotinamide can reduce the incidence of further skin cancers in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone kidney, liver, heart, or lung transplants at least two years prior and have a history of keratinocyte carcinoma.
Not a fit: Patients with untreated localized skin cancer, recent acute rejection episodes, or other specified severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly lower the risk of skin cancer in organ transplant recipients, improving their long-term health outcomes.
How similar studies have performed: Previous studies have shown that nicotinamide can reduce skin cancer rates in immunocompetent individuals, but its efficacy in immunosuppressed transplant recipients is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 6 other locations
- University of Calgary — Calgary, Alberta, Canada (Not_yet_recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: An-Wen Chan — Women's College Hospital
- Study coordinator: Stephanie Jewell, BSc. Hons
- Email: sprintr@wchospital.ca
- Phone: 416 351-3732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.