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

Launched by WOMEN'S COLLEGE HOSPITAL · Jul 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a form of Vitamin B3 called nicotinamide can help prevent skin cancer in patients who have received organ transplants, such as kidney, liver, heart, or lung transplants. Many of these patients are at a higher risk of developing skin cancer due to the medications they take to prevent their bodies from rejecting the new organ. The trial will involve about 396 adult participants who have had at least one skin cancer in the past and are currently taking immune-suppressing medications.

To take part in the study, participants need to be at least 18 years old and must have received their organ transplant at least two years ago. They should also be able to attend follow-up visits during the trial. Those who qualify will receive either nicotinamide or a placebo (a pill that looks the same but contains no active medication) for up to four years. This trial aims to determine if nicotinamide is effective and safe for preventing skin cancer, which could greatly improve the long-term health and quality of life for organ transplant recipients.

Gender

ALL

Eligibility 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