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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03769285
Ethics application status
Date submitted
4/12/2018
Date registered
7/12/2018

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)
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Feasibility (pertaining to appropriateness of eligibility criteria)
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Feasibility (pertaining to adherence to intervention)
Timepoint [3] 0 0
1 year
Primary outcome [4] 0 0
Feasibility (pertaining to adherence to follow-up assessments)
Timepoint [4] 0 0
1 year
Primary outcome [5] 0 0
Feasibility (pertaining to data linkage)
Timepoint [5] 0 0
1 year
Primary outcome [6] 0 0
Preliminary pooled keratinocyte carcinoma event rate
Timepoint [6] 0 0
1 year
Primary outcome [7] 0 0
Drug interactions
Timepoint [7] 0 0
1 week
Primary outcome [8] 0 0
Drug interactions
Timepoint [8] 0 0
2 weeks
Primary outcome [9] 0 0
Serious adverse events
Timepoint [9] 0 0
1 year
Secondary outcome [1] 0 0
Feasibility of recruiting for neurocognitive substudy
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Baseline prevalence of cognitive impairment (substudy)
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Pooled standard deviation of MoCA test scores (substudy)
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
Pooled standard deviation of Trail Making A and B test scores (substudy)
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
Pooled standard deviation of Controlled Oral Word Association test scores (substudy)
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
Pooled standard deviation of Animal Naming Task scores (substudy)
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
Pooled standard deviation of cognitive test scores (substudy)
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
Sex
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 (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 (250 mg or more daily) 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
Accrual to date
Final
120
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
Government body
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
2 years after completion of the pivotal trial that follows this pilot trial
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03769285