A Phase 2 interventional study of Nicotinamide and Placebo oral capsule in Non-melanoma Skin Cancer, Carcinoma, Squamous Cell and Carcinoma, Basal Cell, sponsored by Women's College Hospital. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Women's College Hospital · Phase 2, Interventional, and Prevention
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 120 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Women's College Hospital is the lead sponsor of 83 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Nicotinamide
Drug: Placebo oral capsule
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Also known as: niacinamide
Matching placebo taken twice daily for at least 52 weeks
Feasibility (pertaining to patient recruitment)
Proportion of patients who consent to data linkage to provincial administrative databases
Time frame: 1 year
Feasibility (pertaining to appropriateness of eligibility criteria)
Reasons for exclusion of screened patients
Time frame: 1 year
Feasibility (pertaining to adherence to intervention)
Proportion of capsules returned, reasons for non-adherence
Time frame: 1 year
Feasibility (pertaining to adherence to follow-up assessments)
Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation
Time frame: 1 year
Feasibility (pertaining to data linkage)
Proportion of patients who consent to data linkage to provincial administrative databases
Time frame: 1 year
Preliminary pooled keratinocyte carcinoma event rate
Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
Time frame: 1 year
Drug interactions
Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 1 week. An increased level will be classified as clinically relevant if the transplant physician reduces the immunosuppressant dose in response to the increased drug level.
Time frame: 1 week
Drug interactions
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.
Time frame: 2 weeks
Serious adverse events
Descriptive tabulation (preliminary safety)
Time frame: 1 year
Feasibility of recruiting for neurocognitive substudy
Proportion of enrolled participants who consent to participate in the neurocognitive substudy
Time frame: 1 year
Baseline prevalence of cognitive impairment (substudy)
Montreal Cognitive Assessment (MoCA) score \<26, scored out of 30.
Time frame: 1 year
Pooled standard deviation of MoCA test scores (substudy)
Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function
Time frame: 1 year
Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)
Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory
Time frame: 1 year
Pooled standard deviation of Trail Making A and B test scores (substudy)
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
Time frame: 1 year
Pooled standard deviation of Controlled Oral Word Association test scores (substudy)
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.
Time frame: 1 year
Pooled standard deviation of Animal Naming Task scores (substudy)
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
Time frame: 1 year
Pooled standard deviation of cognitive test scores (substudy)
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
Time frame: 1 year
Pooled standard deviation of serum phosphate levels (substudy)
Time frame: 1 year
Plan to share: Yes — If feasibility thresholds are met, this pilot trial will proceed to a larger pivotal trial. The study protocol for the pivotal trial will be published prior to completion of data collection. Beyond 2 years after completion of the pivotal trial, the cleaned, anonymized, participant-level dataset and statistical code will made available for sharing with external researchers upon approval of a study proposal describing the intended data usage.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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