Nicotinamide for Non-melanoma Skin Cancer

(SPRINTR Trial)

Recruiting at 7 trial locations

Overseen By Stephanie Jewell, BSc. Hons

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Women's College Hospital

Must be taking: Calcineurin inhibitors

Must not be taking: Nicotinamide, Niacin, Carbamazepine, Primidone

Disqualifiers: Active liver disease, Severe kidney disease, Solid organ malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 208 weeks

396 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nicotinamide, a form of Vitamin B3, can help prevent skin cancer in transplant patients. Individuals who have undergone a kidney, liver, heart, or lung transplant and have previously had skin cancer might consider joining. Participants will take either nicotinamide or a placebo (a harmless pill with no active ingredient) for up to four years. The goal is to assess whether nicotinamide is safe and effective for these patients, potentially reducing their risk of skin cancer caused by anti-rejection drugs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have used nicotinamide or niacin in high doses recently, and you cannot be on carbamazepine or primidone. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that nicotinamide is safe for people. Research indicates that taking up to 1 gram per day over a long period is usually well-tolerated, with most people not experiencing serious side effects. This is encouraging because the current trial uses a dose of 500 mg taken twice daily.

While some side effects can occur, they are usually mild. For instance, some people might experience an upset stomach or headaches, but these are uncommon. Overall, nicotinamide has been used safely in other studies, particularly for preventing skin cancer. This suggests it should be safe for transplant patients in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Nicotinamide is unique because it offers a new approach to preventing non-melanoma skin cancers by enhancing DNA repair and reducing inflammation, unlike traditional treatments that often focus on surgical removal or topical therapies. Unlike the standard care options like excision or topical fluorouracil, nicotinamide is a vitamin B3 derivative that can be taken orally, potentially offering a non-invasive and easy-to-administer alternative. Researchers are excited because it could provide a simple, preventative option with fewer side effects, making it a promising addition to current skin cancer prevention strategies.

What evidence suggests that nicotinamide might be an effective treatment for skin cancer in transplant recipients?

Research has shown that nicotinamide, a type of Vitamin B3, can help lower the risk of skin cancer. Studies have found that taking 500 mg of nicotinamide twice a day can reduce the chance of new skin cancers by up to 54% after a previous occurrence. One study showed a 23% drop in new cases of common skin cancers, such as squamous-cell and basal-cell cancers, compared to a placebo over a year. Long-term use at this dose is also safe. In this trial, participants will receive either nicotinamide or a placebo to evaluate its effectiveness in preventing skin cancer. These findings suggest nicotinamide could be a good option for preventing skin cancer, especially for people at high risk. ^{1 2 3 4 5}

Who Is on the Research Team?

An-Wen Chan

Principal Investigator

Women's College Hospital

Sang Joseph Kim

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adult organ transplant recipients who are on specific immunosuppressants, have had a kidney, liver, heart, or lung transplant over two years ago and have previously had skin cancer. They must be able to attend follow-up visits but can't join if they've used certain vitamins recently, had other cancers or severe organ disease in the last five years, are pregnant or breastfeeding.

Inclusion Criteria

I had a transplant (kidney, liver, heart, or lung) over two years ago.

I can go to all my follow-up appointments.

I am on immunosuppressants like cyclosporine or tacrolimus.

Exclusion Criteria

Pregnancy or lactation

I have had a serious cancer or skin cancer spread in the last 5 years.

I have skin cancer that hasn't been treated yet, but I can join after treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral nicotinamide (500 mg twice daily) or placebo for up to 208 weeks

208 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotinamide
• Placebo

Trial Overview The study tests whether Nicotinamide (Vitamin B3) can prevent skin cancer in patients with organ transplants who are at high risk due to their anti-rejection medications. Participants will receive either Nicotinamide or placebo pills twice daily for up to four years across multiple Canadian centers.

How Is the Trial Designed?

Group I: Nicotinamide Experimental Treatment 1 Intervention

Intervention Drug : Nicotinamide

Group II: Placebo Placebo Group 1 Intervention

Intervention: Placebo Oral Capsule

Nicotinamide is already approved in United States, European Union for the following indications:

Approved in United States as Nicotinamide for:

• Pellagra
• Acne vulgaris
• Rosacea
• Hyperpigmentation
• Hair thinning

Approved in European Union as Nicotinamide for:

• Pellagra
• Acne vulgaris
• Rosacea
• Hyperpigmentation
• Hair thinning

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

NOW Foods

Collaborator

Trials

6

Recruited

690+

Published Research Related to This Trial

A significant majority (76.9%) of Mohs surgeons recommend nicotinamide for preventing keratinocyte carcinoma (KC), indicating its acceptance as a preventive treatment in clinical practice.

Most surgeons (63.8%) have no safety concerns regarding long-term use of nicotinamide, although those with safety concerns and more experienced surgeons (over 10 years in practice) were less likely to recommend it, suggesting a need for further research on its long-term safety and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide for Keratinocyte Carcinoma Chemoprevention: A Nationwide Survey of Mohs Surgeons. Desai, S., Olbricht, S., Ruiz, ES., et al.[2021]

Nicotinamide (vitamin B3) has demonstrated multiple protective effects against UV damage, including enhancing DNA repair and restoring cellular energy levels, which can help maintain skin health.

In high-risk individuals, pharmacological doses of nicotinamide significantly reduce the incidence of actinic keratoses and nonmelanoma skin cancers, making it a safe and effective option for skin cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide for skin cancer chemoprevention. Damian, DL.[2018]

Oral nicotinamide supplementation has been studied in five randomized controlled trials and other studies, showing a potential benefit in reducing the incidence of non-melanoma skin cancers (NMSC), particularly in high-risk individuals.

While current evidence is not definitive, nicotinamide has a favorable safety profile, making it a low-risk option for managing skin cancer risk, especially for those with a history of skin issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nicotinamide for non-melanoma skin cancers: A review. Hunt, SV., Jamison, A., Malhotra, R.[2023]

A survey of 50 patients who underwent Mohs surgery revealed that those taking nicotinamide perceived a higher risk reduction for basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), with reductions of 41.2% and 38.3%, respectively.

Despite a significant perceived benefit, only 15.6% of respondents believed nicotinamide was more effective than sunscreen, highlighting the need for better patient education on the role of nicotinamide in reducing skin cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perception of Skin Cancer Reduction by Nicotinamide Correlates With Use. Schneider, JG., Majidian, M., Moy, RL.[2023]

In a study of 203 adults with a history of multiple non-melanoma skin cancers, patients were willing to accept a 23% reduction in skin cancer risk with a modest increase in cost, but they were not willing to accept a significant increase in severe infection risk associated with nicotinamide supplementation.

The findings suggest that while nicotinamide can reduce skin cancer risk, the potential for increased severe infections may deter patients from choosing this treatment, indicating a need for careful consideration of patient preferences in treatment recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' willingness to accept adverse event and cost tradeoffs from oral nicotinamide for reduced risk of non-melanoma skin cancer. Boeri, M., Skelsey, MK., Schiro, JA., et al.[2023]

Nicotinamide (NAM), a form of vitamin B3, has been shown to significantly reduce the incidence of actinic keratoses and non-melanoma skin cancers in a Phase III double-blinded placebo-controlled study involving skin cancer patients.

While NAM is effective in preventing skin cancer, its benefits require continuous supplementation, as the protective effects diminish quickly after stopping intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nicotinamide: The role in skin cancer chemoprevention. Giacalone, S., Spigariolo, CB., Bortoluzzi, P., et al.[2021]

Oral nicotinamide supplementation may help lower the risk of non-melanoma skin cancers, suggesting a potential preventive strategy for at-risk individuals.

Despite the current lack of definitive proof, nicotinamide is considered safe with a favorable side effect profile, making it a viable option for those at higher risk of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide and Nonmelanoma Skin Cancers. Jamison, A., Malhotra, R.[2022]

Citations

1. news.vumc.org news.vumc.org/2025/09/17/study-reveals-efficacy-of-nicotinamide-for-skin-cancer-prevention/

Study reveals efficacy of nicotinamide for skin cancer ... Overall, there was a 14% reduction in skin cancer risk. When nicotinamide was taken after a first skin cancer, the risk reduction rose to ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/article-abstract/2838591

Nicotinamide for Skin Cancer Chemoprevention When nicotinamide was initiated after a first skin cancer, the risk reduction rose to 54%, although this benefit declined with initiation ...

3. npr.org npr.org/2025/09/17/nx-s1-5544145/vitamin-b3-can-help-protect-against-skin-cancer-heres-who-may-benefit

Vitamin B3 may help prevent skin cancer, new study finds Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4570055/

Oral Nicotinamide Prevents Common Skin Cancers in High ... The pill—the vitamin B3 supplement called nicotinamide—cut the rate of new squamous-cell and basal-cell skin cancers by 23% compared with placebo after 1 year ...

5. jaadreviews.org jaadreviews.org/article/S2950-1989(25)00079-0/fulltext

Examining the safety of nicotinamide for skin cancer ... In patients without risk factors, long-term doses of up to 1 g/d are well-tolerated. While limited studies provide reassurance of relative lack ...