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
| Sponsors |
Lead Sponsor: Women's College Hospital Collaborator:
Canadian Institutes of Health Research (CIHR)
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| Source | Women's College Hospital | ||||||||||||||||||||
| 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 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. |
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| Overall Status | Recruiting | ||||||||||||||||||||
| Start Date | December 3, 2018 | ||||||||||||||||||||
| Completion Date | December 2020 | ||||||||||||||||||||
| Primary Completion Date | December 2020 | ||||||||||||||||||||
| Phase | Phase 2 | ||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 120 | ||||||||||||||||||||
| Condition | |||||||||||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Nicotinamide Description: Oral nicotinamide (500 mg) twice daily for at least 52 weeks Arm Group Label: Nicotinamide Other Name: niacinamide Intervention Type: Drug Intervention Name: Placebo oral capsule Description: Matching placebo taken twice daily for at least 52 weeks Arm Group Label: Placebo |
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| Eligibility |
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years old 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: 1. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks 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 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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Overall Official |
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| Overall Contact |
Last Name: Ashley Lau, BMRSc Phone: 416-351-3732 Phone Ext.: 2706 Email: [email protected] |
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| Location |
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| Location Countries |
Canada |
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| Verification Date |
June 2019 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||||||||||||
| Condition Browse | |||||||||||||||||||||
| Number Of Arms | 2 | ||||||||||||||||||||
| Arm Group |
Label: Nicotinamide Type: Experimental Label: Placebo Type: Placebo Comparator |
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| Acronym | SPRINTR-Pilot | ||||||||||||||||||||
| Patient Data | Yes | ||||||||||||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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