Status:
UNKNOWN
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
Lead Sponsor:
Women's College Hospital
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
Conditions:
Non-melanoma Skin Cancer
Carcinoma, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03769285
Start Date
December 3 2018
End Date
December 1 2023
Last Update
April 6 2023
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2N2