Non-melanoma Skin CancerPhase 2SPRINTR-PilotNCT03769285
Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial
A Phase 2 study testing Nicotinamide in people with Non-melanoma Skin Cancer and Carcinoma, Squamous Cell, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-melanoma Skin Cancer, Carcinoma, Squamous Cell, Carcinoma, Basal Cell
- What is being tested?
- Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2018to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2N2
About this study
Official title: Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
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.
- Being tested
- Nicotinamide, Placebo oral capsule
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDrug
Also called niacinamide
Oral nicotinamide (500 mg) twice daily for at least 52 weeks
Placebo oral capsuleDrug
Matching placebo taken twice daily for at least 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide | Experimental | Not described Receives: Drug: Nicotinamide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (pertaining to patient recruitment)
Proportion of patients who consent to data linkage to provincial administrative databases
Measured: 1 year
Feasibility (pertaining to appropriateness of eligibility criteria)
Reasons for exclusion of screened patients
Measured: 1 year
Feasibility (pertaining to adherence to intervention)
Proportion of capsules returned, reasons for non-adherence
Measured: 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
Measured: 1 year
Feasibility (pertaining to data linkage)
Proportion of patients who consent to data linkage to provincial administrative databases
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Serious adverse events
Descriptive tabulation (preliminary safety)
Measured: 1 year
Secondary outcomes (9)
Feasibility of recruiting for neurocognitive substudy
Proportion of enrolled participants who consent to participate in the neurocognitive substudy
Measured: 1 year
Baseline prevalence of cognitive impairment (substudy)
Montreal Cognitive Assessment (MoCA) score <26, scored out of 30.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 year
Pooled standard deviation of serum phosphate levels (substudy)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start3 Dec 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada, NOW Foods, Natural Life Nutrition
- Responsible party
- Sponsor
- Investigators
- An-Wen Chan, MD DPhil, Principal investigator, Women's College HospitalJoseph Kim, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769285
- Sponsor's protocol ID
- SPRINTR-Pilot
- Acronym
- SPRINTR-Pilot
- Status last verified
- Mar 2023
- First submitted
- 4 Dec 2018
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: A Pilot, Placebo-controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT03769285
- Acronym / sponsor ID
- SPRINTR-Pilot / SPRINTR-Pilot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada, NOW Foods, Natural Life Nutrition
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide | Experimental | Drug: Nicotinamide |
| Placebo | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotinamideAlso: niacinamideOral nicotinamide (500 mg) twice daily for at least 52 weeks | Drug | Nicotinamide |
| Placebo oral capsuleMatching placebo taken twice daily for at least 52 weeks | Drug | Placebo |
Primary outcome
Feasibility (pertaining to patient recruitment)
Time frame: 1 year
Proportion of patients who consent to data linkage to provincial administrative databases
Feasibility (pertaining to appropriateness of eligibility criteria)
Time frame: 1 year
Reasons for exclusion of screened patients
Feasibility (pertaining to adherence to intervention)
Time frame: 1 year
Proportion of capsules returned, reasons for non-adherence
Feasibility (pertaining to adherence to follow-up assessments)
Time frame: 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)
Time frame: 1 year
Proportion of patients who consent to data linkage to provincial administrative databases
Preliminary pooled keratinocyte carcinoma event rate
Time frame: 1 year
Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.
Drug interactions
Time frame: 1 week
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.
Drug interactions
Time frame: 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
Time frame: 1 year
Descriptive tabulation (preliminary safety)
9 secondary outcomes
Feasibility of recruiting for neurocognitive substudy
Time frame: 1 year
Baseline prevalence of cognitive impairment (substudy)
Time frame: 1 year
Pooled standard deviation of MoCA test scores (substudy)
Time frame: 1 year
Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)
Time frame: 1 year
Pooled standard deviation of Trail Making A and B test scores (substudy)
Time frame: 1 year
Pooled standard deviation of Controlled Oral Word Association test scores (substudy)
Time frame: 1 year
Pooled standard deviation of Animal Naming Task scores (substudy)
Time frame: 1 year
Pooled standard deviation of cognitive test scores (substudy)
Time frame: 1 year
Pooled standard deviation of serum phosphate levels (substudy)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An-Wen Chan, MD DPhil principal investigator
Women's College Hospital
Joseph Kim, MD PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide in people with Non-melanoma Skin Cancer and Carcinoma, Squamous Cell, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (pertaining to patient recruitment) (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.