Non-melanoma Skin Cancer study: Nicotinamide
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?
An investigational oral medication being studied to prevent non‑melanoma skin cancer in organ transplant recipients. is designed to support DNA repair and reduce skin damage from ultraviolet light.
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
- This study is testing whether taking nicotinamide twice a day can prevent new skin cancers in people who have had an organ transplant.
- Who it's for
- You may be able to join if you are an adult who had a kidney, liver, heart, or lung transplant and have had at least one skin cancer before.
- What's involved
- You will take a pill with 500 mg of nicotinamide twice daily or a pretend pill that looks the same. You will have regular check‑ins at the clinic to look for new skin cancers and to report any side effects.
- Time commitment
- The study lasts up to 4 years, with visits every few months to monitor your skin and health.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.