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Prevention study for Non-melanoma Skin Cancer
Official title Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
ClinicalTrials.gov ID: NCT05955924
What this study is testing
What is Nicotinamide?
Nicotinamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-melanoma skin cancer.
Also referred to as niacinamide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.