The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03769285




Registration number
NCT03769285
Ethics application status
Date submitted
1/12/2018
Date registered
6/12/2018
Date last updated
12/12/2018

Titles & IDs
Public title
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
Scientific title
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
Secondary ID [1] 0 0
SPRINTR-Pilot
Universal Trial Number (UTN)
Trial acronym
SPRINTR-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-melanoma Skin Cancer 0 0
Carcinoma, Squamous Cell 0 0
Carcinoma, Basal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nicotinamide
Treatment: Drugs - Placebo oral capsule

Experimental: Nicotinamide -

Placebo Comparator: Placebo -


Treatment: Drugs: Nicotinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks

Treatment: Drugs: Placebo oral capsule
Matching placebo taken twice daily for at least 52 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility (pertaining to patient recruitment) - Proportion of patients who consent to data linkage to provincial administrative databases
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Feasibility (pertaining to appropriateness of eligibility criteria) - Reasons for exclusion of screened patients
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Feasibility (pertaining to adherence to intervention) - Proportion of capsules returned, reasons for non-adherence
Timepoint [3] 0 0
1 year
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
1 year
Primary outcome [5] 0 0
Feasibility (pertaining to data linkage) - Proportion of patients who consent to data linkage to provincial administrative databases
Timepoint [5] 0 0
1 year
Primary outcome [6] 0 0
Preliminary pooled keratinocyte carcinoma event rate - Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
Timepoint [6] 0 0
1 year
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
1 week
Primary outcome [8] 0 0
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.
Timepoint [8] 0 0
2 weeks
Primary outcome [9] 0 0
Serious adverse events - Descriptive tabulation (preliminary safety)
Timepoint [9] 0 0
1 year
Secondary outcome [1] 0 0
Feasibility of recruiting for neurocognitive substudy - Proportion of enrolled participants who consent to participate in the neurocognitive substudy
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Baseline prevalence of cognitive impairment (substudy) - Montreal Cognitive Assessment (MoCA) score <26, scored out of 30.
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
Pooled standard deviation of serum phosphate levels (substudy)
Timepoint [9] 0 0
1 year

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 at baseline

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Women's College Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Kidney Foundation of Canada
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
NOW Foods
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Natural Life Nutrition
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03769285
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
An-Wen Chan, MD DPhil
Address 0 0
Women's College Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ashley Lau, BMRSc
Address 0 0
Country 0 0
Phone 0 0
416-351-3732
Fax 0 0
Email 0 0
ashley.lau@wchospital.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03769285