Trial Review

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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
Date last updated
6/04/2023

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
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

Funding & Sponsors
Primary sponsor type
Other
Name
Women's College Hospital
Address
Country

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/study/NCT03769285
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

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