Non-melanoma Skin CancerPhase 3SPRINTRNCT05955924
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
A Phase 3 study testing Nicotinamide in people with Non-melanoma Skin Cancer and Carcinoma, Squamous Cell, run by Women's College Hospital at 7 sites in Canada.
Trial summary
As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. 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
- 396 participants
- Where
- 7 sitesCanada
- Study dates
- 28 Aug 2023to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who cannot join
- Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks
- Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)
- Biopsy-confirmed acute rejection episode within the past 12 weeks
- Active liver disease (high AST >3 times or bilirubin >1.5 times)
- Severe kidney disease (estimated glomerular filtration rate <20 mL/min/1.73 m2)
- Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years
Show all 9Show fewer
- Pregnancy or lactation
- Need for ongoing carbamazepine or primidone
- Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Coralea Bignell, coralea.bignell@albertahealthservices.ca
Ngam Lam
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2R3
Kelly Kim, kkim6@ualberta.ca
Sita Gourishankar
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Christine Lennox, clennox@ohri.ca
Jennifer Beecker
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Marsida Stafa, SPRINTR@wchospital.ca
An-Wen Chan
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B2
Stephanie Jewell, SPRINTR@wchospital.ca
An-Wen Chan
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Natalie Ng, natalie.ng@ubc.ca
Sunil Kalia
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Anushka Sood, asood1@providencehealth.bc.ca
John Gill
About this study
Official title: Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial
As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical.
Nicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.
Read the detailed description
Improved survival after solid organ transplantation has created the need to better prevent the long-term adverse effects of immunosuppressant drugs in transplant survivors - particularly cancer development. Keratinocyte carcinoma (non-melanoma skin cancer) is by far the most common form of post-transplant malignancy and has a more aggressive clinical course than in the general population. Preventive measures are thus critical to reduce the burden of skin cancer in the high-risk transplant population.
Nicotinamide is a low-cost, commercially available, over-the-counter Vitamin B3 derivative that has been found to safely reduce the rate of keratinocyte carcinoma in immunocompetent patients with a history of skin cancer. It is unclear whether its efficacy and safety translate to the immunosuppressed transplant population.
Given this uncertainty, Investigators plan to build on our internal pilot study (N=120) to conduct the SPRINTR (Skin cancer PRevention with Nicotinamide in Transplant Recipients) pivotal trial to address these specific aims:
Primary question: Does oral nicotinamide (500 mg twice daily) reduce the rate of further keratinocyte carcinoma compared with placebo when used in addition to standard care for up to 208 weeks in high-risk solid organ transplant recipients?
Secondary questions:
- What is the safety of nicotinamide when used in addition to standard care for up to 208 weeks in the transplant population?
- What is the effect of nicotinamide on quality of life related to skin cancer?
Investigators will conduct a multicentre, pragmatic, parallel group, investigator- and patient-blinded, randomized trial with a superiority framework. This pivotal trial will evaluate the efficacy and safety of oral nicotinamide versus placebo to prevent further keratinocyte carcinoma in 396 high-risk solid organ transplant recipients. Data from our previous internal pilot study (N=120 participants) will be combined with data from the current pivotal trial (N=276 additional patients) in the final analysis.
- Conditions
- Non-melanoma Skin Cancer, Carcinoma, Squamous Cell, Carcinoma, Basal Cell, Keratinocyte Carcinoma
- Being tested
- Nicotinamide, Placebo
- 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
PlaceboDrug
Matching placebo capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide | Experimental | Intervention Drug : Nicotinamide Receives: Drug: Nicotinamide |
| Placebo | Placebo comparator | Intervention: Placebo Oral Capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first biopsy-confirmed keratinocyte carcinoma (basal cell carcinoma or invasive cutaneous squamous cell carcinoma)
Measured: Up to 208 weeks
Secondary outcomes (43)
Time to first invasive squamous cell carcinoma during follow-up
Measured: Up to 208 weeks
Time to first basal cell carcinoma during follow-up
Measured: Up to 208 weeks
Time to multiple keratinocyte carcinomas over follow-up
Measured: Up to 208 weeks
Occurrence of adverse events during follow-up
Overall and by body system, frequency, seriousness, and severity
Measured: 208 weeks
Acute graft rejection (biopsy-confirmed)
Adverse event
Measured: 208 weeks
Graft loss or retransplantation
Adverse event
Measured: 208 weeks
High/low cyclosporine or tacrolimus blood concentration requiring dose adjustment
Adverse event
Measured: 208 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Measured: 52 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Measured: 104 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Measured: 156 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Measured: 208 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
As defined by the International Cognition and Cancer Task Force (T scores ≥2 standard deviations below the normative population mean on a single test, or ≥1.5 standard deviations below the mean on at least two tests, or both)
Measured: 52 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
As defined by the International Cognition and Cancer Task Force (T scores ≥2 standard deviations below the normative population mean on a single test, or ≥1.5 standard deviations below the mean on at least two tests, or both)
Measured: 104 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
As defined by the International Cognition and Cancer Task Force (T scores ≥2 standard deviations below the normative population mean on a single test, or ≥1.5 standard deviations below the mean on at least two tests, or both)
Measured: 156 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
As defined by the International Cognition and Cancer Task Force (T scores ≥2 standard deviations below the normative population mean on a single test, or ≥1.5 standard deviations below the mean on at least two tests, or both)
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Measured: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest
Measured: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest
Measured: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest
Measured: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest
Measured: 208 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start28 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, parallel group, placebo-controlled, pragmatic randomized trial with 1:1 allocation and a superiority framework
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, NOW Foods
- Responsible party
- Sponsor
- Investigators
- An-Wen Chan, Principal investigator, Women's College HospitalSang Joseph Kim, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955924
- Sponsor's protocol ID
- SPRINTR-pivotal
- Acronym
- SPRINTR
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial protocol and statistical code will be shared upon request. Beyond 18 months after trial completion, the anonymized participant-level dataset will made available for sharing with external researchers upon approval of a reasonable study proposal describing the intended data usage.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. 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 Multicentre, Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT05955924
- Acronym / sponsor ID
- SPRINTR / SPRINTR-pivotal
- Conditions
- Non-melanoma Skin Cancer, Carcinoma, Squamous Cell, Carcinoma, Basal Cell, Keratinocyte Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University Health Network, Toronto, NOW Foods
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Jul 2023 (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.
As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical.
Nicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.
Detailed description
Improved survival after solid organ transplantation has created the need to better prevent the long-term adverse effects of immunosuppressant drugs in transplant survivors - particularly cancer development. Keratinocyte carcinoma (non-melanoma skin cancer) is by far the most common form of post-transplant malignancy and has a more aggressive clinical course than in the general population. Preventive measures are thus critical to reduce the burden of skin cancer in the high-risk transplant population.
Nicotinamide is a low-cost, commercially available, over-the-counter Vitamin B3 derivative that has been found to safely reduce the rate of keratinocyte carcinoma in immunocompetent patients with a history of skin cancer. It is unclear whether its efficacy and safety translate to the immunosuppressed transplant population.
Given this uncertainty, Investigators plan to build on our internal pilot study (N=120) to conduct the SPRINTR (Skin cancer PRevention with Nicotinamide in Transplant Recipients) pivotal trial to address these specific aims:
Primary question: Does oral nicotinamide (500 mg twice daily) reduce the rate of further keratinocyte carcinoma compared with placebo when used in addition to standard care for up to 208 weeks in high-risk solid organ transplant recipients?
Secondary questions:
- What is the safety of nicotinamide when used in addition to standard care for up to 208 weeks in the transplant population?
- What is the effect of nicotinamide on quality of life related to skin cancer?
Investigators will conduct a multicentre, pragmatic, parallel group, investigator- and patient-blinded, randomized trial with a superiority framework. This pivotal trial will evaluate the efficacy and safety of oral nicotinamide versus placebo to prevent further keratinocyte carcinoma in 396 high-risk solid organ transplant recipients. Data from our previous internal pilot study (N=120 participants) will be combined with data from the current pivotal trial (N=276 additional patients) in the final analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, parallel group, placebo-controlled, pragmatic randomized trial with 1:1 allocation and a superiority framework
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide | Experimental | Drug: NicotinamideIntervention Drug : Nicotinamide |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: 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 (5 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 (9 listed)
- Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks
- Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)
- Biopsy-confirmed acute rejection episode within the past 12 weeks
- Active liver disease (high AST >3 times or bilirubin >1.5 times)
- Severe kidney disease (estimated glomerular filtration rate <20 mL/min/1.73 m2)
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 | Drug | Nicotinamide |
| PlaceboMatching placebo capsule twice daily | Drug | Placebo |
Primary outcome
Time to first biopsy-confirmed keratinocyte carcinoma (basal cell carcinoma or invasive cutaneous squamous cell carcinoma)
Time frame: Up to 208 weeks
43 secondary outcomes
Time to first invasive squamous cell carcinoma during follow-up
Time frame: Up to 208 weeks
Time to first basal cell carcinoma during follow-up
Time frame: Up to 208 weeks
Time to multiple keratinocyte carcinomas over follow-up
Time frame: Up to 208 weeks
Occurrence of adverse events during follow-up
Time frame: 208 weeks
Acute graft rejection (biopsy-confirmed)
Time frame: 208 weeks
Graft loss or retransplantation
Time frame: 208 weeks
High/low cyclosporine or tacrolimus blood concentration requiring dose adjustment
Time frame: 208 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Time frame: 52 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Time frame: 104 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Time frame: 156 weeks
Change from baseline in annual Basal and Squamous Cell Carcinoma Quality of Life (BaSQoL) score
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Montreal Cognitive Assessment (MoCA)
Time frame: 208 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
Time frame: 52 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
Time frame: 104 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
Time frame: 156 weeks
Neurocognitive substudy - Proportion of participants with cognitive impairment
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Hopkins Verbal Learning Test - Revised
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Trail Making A and B
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Controlled Oral Word Association
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Animal Naming Task
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Time frame: 52 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Time frame: 104 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Time frame: 156 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Wechsler Adult Intelligence Scale-Fourth Edition-Canadian (WAIS-IV-CDN).
Time frame: 208 weeks
Neurocognitive substudy - Change from baseline in demographically-corrected T score for Digit Span subtest
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. The trial protocol and statistical code will be shared upon request. Beyond 18 months after trial completion, the anonymized participant-level dataset will made available for sharing with external researchers upon approval of a reasonable 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.
An-Wen Chan principal investigator
Women's College Hospital
Sang Joseph Kim principal investigator
University Health Network, Toronto
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotinamide in people with Non-melanoma Skin Cancer and Carcinoma, Squamous Cell, run by Women's College Hospital at 7 sites 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Jewell, BSc. Hons (416 351-3732 ext. 2706, sprintr@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first biopsy-confirmed keratinocyte carcinoma (basal cell carcinoma or invasive cutaneous squamous cell carcinoma) (time frame: Up to 208 weeks). 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 13 Oct 2026.