Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
- Conditions
- Non-melanoma Skin CancerCarcinoma, Squamous CellCarcinoma, Basal Cell
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03769285
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nicotinamide Nicotinamide - Placebo Placebo oral capsule -
- Primary Outcome Measures
Name Time Method Feasibility (pertaining to patient recruitment) 1 year Proportion of patients who consent to data linkage to provincial administrative databases
Feasibility (pertaining to appropriateness of eligibility criteria) 1 year Reasons for exclusion of screened patients
Feasibility (pertaining to adherence to intervention) 1 year Proportion of capsules returned, reasons for non-adherence
Feasibility (pertaining to adherence to follow-up assessments) 1 year Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation
Feasibility (pertaining to data linkage) 1 year Proportion of patients who consent to data linkage to provincial administrative databases
Drug interactions 2 weeks Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.
Serious adverse events 1 year Descriptive tabulation (preliminary safety)
Preliminary pooled keratinocyte carcinoma event rate 1 year Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
- Secondary Outcome Measures
Name Time Method Pooled standard deviation of Animal Naming Task scores (substudy) 1 year Animal Naming Task, a verbal fluency task, measures the total number of animals named in one minute, with a higher number representing better verbal fluency
Pooled standard deviation of cognitive test scores (substudy) 1 year Wechsler Adult Intelligence Scale - Revised, Digit Span subtest, a number sequencing memory test, measures the number of correctly repeated sequences with maximum score of 48. The higher score represents better cognitive function
Pooled standard deviation of serum phosphate levels (substudy) 1 year Pooled standard deviation of Trail Making A and B test scores (substudy) 1 year Trail Making A and B, a visual attention test. This records the time (in seconds) to completion, with a faster time representing better cognitive function
Pooled standard deviation of Controlled Oral Word Association test scores (substudy) 1 year Controlled Oral Word Association, a verbal fluency test, measures the production of words belonging to the same letter. This records total number of words produced, with a higher number representing better verbal fluency.
Feasibility of recruiting for neurocognitive substudy 1 year Proportion of enrolled participants who consent to participate in the neurocognitive substudy
Pooled standard deviation of MoCA test scores (substudy) 1 year Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function
Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy) 1 year Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory
Baseline prevalence of cognitive impairment (substudy) 1 year Montreal Cognitive Assessment (MoCA) score \<26, scored out of 30.
Trial Locations
- Locations (1)
Toronto General Hospital, University Health Network
🇨🇦Toronto, Ontario, Canada