Trial | NCT03769285  Report issue

Title

Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    Nicotinamide ...

  • Study Participants

    120
A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.
Study Started
Dec 03
2018
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Dec 31
2023
Anticipated
Last Update
Apr 06
2023

Drug Nicotinamide

Oral nicotinamide (500 mg) twice daily for at least 52 weeks

  • Other names: niacinamide

Drug Placebo oral capsule

Matching placebo taken twice daily for at least 52 weeks

Nicotinamide Experimental

Placebo Placebo Comparator

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
Able to speak and understand English (only for cognitive substudy)

Exclusion Criteria:

Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks
Biopsy-confirmed acute rejection episode within the past 12 weeks
Active liver disease (elevated AST or ALT >3 times normal)
Severe renal failure (estimated glomerular filtration rate <20 mL/min/1.73 m2)
Current carbamazepine or primidone use
Pregnancy and lactation
Gorlin syndrome or other genetic skin cancer syndrome
Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years
Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)
Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks
Use of field therapy for actinic keratoses within the past 12 weeks
Initiation of systemic chemoprevention within the past 12 weeks
No Results Posted