Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
NCT ID: NCT03769285
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2018-12-03
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Nicotinamide
Nicotinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Placebo
Placebo oral capsule
Matching placebo taken twice daily for at least 52 weeks
Interventions
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Nicotinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Placebo oral capsule
Matching placebo taken twice daily for at least 52 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Kidney, liver, heart, or lung transplant at least two years ago
3. History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ
4. Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)
5. Able to attend follow-up visits
6. Able to speak and understand English (only for cognitive substudy)
Exclusion Criteria
2. Biopsy-confirmed acute rejection episode within the past 12 weeks
3. Active liver disease (elevated AST or ALT \>3 times normal)
4. Severe renal failure (estimated glomerular filtration rate \<20 mL/min/1.73 m2)
5. Current carbamazepine or primidone use
6. Pregnancy and lactation
7. Gorlin syndrome or other genetic skin cancer syndrome
8. 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
9. Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment)
10. Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks
11. Use of field therapy for actinic keratoses within the past 12 weeks
12. Initiation of systemic chemoprevention within the past 12 weeks
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Kidney Foundation of Canada
OTHER
NOW Foods
OTHER
Natural Life Nutrition
UNKNOWN
Women's College Hospital
OTHER
Responsible Party
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Principal Investigators
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An-Wen Chan, MD DPhil
Role: PRINCIPAL_INVESTIGATOR
Women's College Hospital
Joseph Kim, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Countries
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Other Identifiers
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SPRINTR-Pilot
Identifier Type: -
Identifier Source: org_study_id
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