Preventing skin cancer in organ transplant recipients using nicotinamide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.