Carcinoma, Squamous Cell Clinical Trial
— SPRINTROfficial title:
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial
As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical. Nicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.
Status | Recruiting |
Enrollment | 396 |
Est. completion date | August 2027 |
Est. primary completion date | August 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Canada | University of Alberta | Edmonton | Alberta |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Women's College Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Women's College Hospital | Canadian Institutes of Health Research (CIHR), NOW Foods, University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first biopsy-confirmed keratinocyte carcinoma (basal cell carcinoma or invasive cutaneous squamous cell carcinoma) | Up to 208 weeks | ||
Secondary | Time to first invasive squamous cell carcinoma during follow-up | Up to 208 weeks | ||
Secondary | Time to first basal cell carcinoma during follow-up | Up to 208 weeks | ||
Secondary | Time to multiple keratinocyte carcinomas over follow-up | Up to 208 weeks | ||
Secondary | Occurrence of adverse events during follow-up | Overall and by body system, frequency, seriousness, and severity | 208 weeks | |
Secondary | Acute graft rejection (biopsy-confirmed) | Adverse event | 208 weeks | |
Secondary | Graft loss or retransplantation | Adverse event | 208 weeks | |
Secondary | High/low cyclosporine or tacrolimus blood concentration requiring dose adjustment | Adverse event | 208 weeks | |
Secondary | Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score | 52 weeks | ||
Secondary | Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score | 104 weeks | ||
Secondary | Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score | 156 weeks | ||
Secondary | Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA) | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA) | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA) | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA) | 208 weeks | ||
Secondary | Neurocognitive substudy - Proportion of participants with cognitive impairment | As defined by the International Cognition and Cancer Task Force (T scores =2 standard deviations below the normative population mean on a single test, or =1.5 standard deviations below the mean on at least two tests, or both) | 52 weeks | |
Secondary | Neurocognitive substudy - Proportion of participants with cognitive impairment | As defined by the International Cognition and Cancer Task Force (T scores =2 standard deviations below the normative population mean on a single test, or =1.5 standard deviations below the mean on at least two tests, or both) | 104 weeks | |
Secondary | Neurocognitive substudy - Proportion of participants with cognitive impairment | As defined by the International Cognition and Cancer Task Force (T scores =2 standard deviations below the normative population mean on a single test, or =1.5 standard deviations below the mean on at least two tests, or both) | 156 weeks | |
Secondary | Neurocognitive substudy - Proportion of participants with cognitive impairment | As defined by the International Cognition and Cancer Task Force (T scores =2 standard deviations below the normative population mean on a single test, or =1.5 standard deviations below the mean on at least two tests, or both) | 208 weeks | |
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN). | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN). | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN). | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN). | 208 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest | 52 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest | 104 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest | 156 weeks | ||
Secondary | Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest | 208 weeks |
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