RecruitingPhase 3NCT05955924

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial

Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial


Sponsor

Women's College Hospital

Enrollment

396 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a vitamin B3 supplement called nicotinamide can prevent skin cancer in people who have received an organ transplant. People on anti-rejection medications after transplants have a much higher risk of developing skin cancers, and this trial aims to reduce that risk. **You may be eligible if...** - You are 18 or older - You received a kidney, liver, heart, or lung transplant at least two years ago - You have had at least one confirmed skin cancer (squamous or basal cell type) in the past - You are currently taking anti-rejection medications that include cyclosporine or tacrolimus - You are able to attend follow-up visits **You may NOT be eligible if...** - You currently take high-dose nicotinamide or niacin supplements (250 mg or more daily) - You have untreated skin cancer right now (you may enroll after treatment) - You had a biopsy-confirmed organ rejection episode in the last 3 months - You have active liver or severe kidney disease - You have had a serious cancer (other than skin) in the past 5 years - You are pregnant or breastfeeding - You take carbamazepine or primidone (seizure medications) - You are allergic to nicotinamide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNicotinamide

Oral nicotinamide (500 mg) twice daily

DRUGPlacebo

Matching placebo capsule twice daily


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT05955924


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