Nicotinamide for Chronic Lymphocytic Leukemia and Skin Cancer

Overseen By Lindsey Gilstrap

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Nicotinamide, Niacin, Retinoids, others

Disqualifiers: Chemotherapy, Transplant, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

86 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether oral nicotinamide (also known as niacinamide or Vitamin B3) can prevent new skin cancers in individuals with chronic lymphocytic leukemia (CLL) who have recently experienced a non-melanoma skin cancer. Participants will take either nicotinamide or a placebo (a pill with no active ingredients) for one year, followed by nicotinamide for another year to assess its effect on reducing skin cancer recurrence. The study seeks individuals with CLL who have been diagnosed with at least one non-melanoma skin cancer in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take nicotinamide, niacin supplements, or certain other medications like acitretin within specific time frames before starting. If you're on prohibited medications, a washout period (time without taking them) is required before the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nicotinamide is generally safe for use. Studies have found that most people tolerate it well. For instance, one study discovered that taking nicotinamide orally reduced the risk of new skin cancers, particularly squamous cell carcinoma, by up to 54% and was considered safe. Another study found that nicotinamide lowered the rates of new nonmelanoma skin cancers without causing significant side effects. While monitoring for any negative reactions is important, these findings suggest that nicotinamide is safe and effective in reducing the risk of skin cancer. ^{1 2 3 4 5}

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

Nicotinamide is unique because it offers a novel approach to treating Chronic Lymphocytic Leukemia (CLL) and skin cancer, specifically non-melanoma skin cancer (NMSC). Unlike current treatments that often involve chemotherapy or targeted therapies, nicotinamide is a form of vitamin B3 that is taken orally and has a different mechanism of action. Researchers are excited about this treatment because it could potentially enhance DNA repair and reduce skin cancer risk with fewer side effects, making it a promising, less invasive option. Additionally, it may provide a preventative approach for patients with a history of skin cancer.

What evidence suggests that nicotinamide might be an effective treatment for chronic lymphocytic leukemia and skin cancer?

Research has shown that nicotinamide, a type of vitamin B3, can lower the risk of skin cancer by 14% for most people. This effect increases to a 54% risk reduction for those who have already had skin cancer. These findings come from studies involving large groups, including over 33,000 veterans. In this trial, participants will be randomized to receive either nicotinamide or a placebo for one year, followed by nicotinamide for an additional year. Nicotinamide offers a promising way to prevent new skin cancers after a previous occurrence. It helps repair DNA damage caused by sun exposure, a known cause of skin cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Lindsey Fitzgerald

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia who've had non-melanoma skin cancer in the last 5 years. They must have normal liver function, agree to use contraception if of childbearing potential, and not be on certain medications or treatments that could interfere with the study.

Inclusion Criteria

I have had at least one non-melanoma skin cancer in the past 5 years.

I am not pregnant or I am post-menopausal.

I have been diagnosed with CLL or SLL according to the latest criteria.

Exclusion Criteria

I have not taken acitretin or other oral retinoids in the last 6 months.

You are not expected to live for more than 2 years.

I need to keep taking carbamazepine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Year 1

Participants receive either oral nicotinamide 500 mg twice daily or oral placebo for 1 year. Dermatologic examination and quantification of new NMSC at the end of the year.

52 weeks

Monthly visits for monitoring

Crossover Treatment Year 2

All participants receive Nicotinamide 500 mg BID for an additional year. Dermatologic examination and quantification of new NMSC at the end of the year.

52 weeks

Monthly visits for monitoring

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 trial tests whether Nicotinamide (a form of vitamin B3) taken orally can prevent new non-melanoma skin cancers in CLL patients. Participants are randomly given either Nicotinamide or a placebo for one year, then all receive Nicotinamide for another year while their skin health is monitored.

How Is the Trial Designed?

Group I: Placebo, Then Nicotinamide Experimental Treatment 2 Interventions

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive placebo twice daily (BID) for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will be unblinded, and all patients will receive Nicotinamide 500 mg BID for an additional year.

Group II: Nicotinamide, Then Nicotinamide Experimental Treatment 1 Intervention

Consenting patients with CLL who have had at least one NMSC diagnosed in the past year will be randomized to receive oral nicotinamide 500 mg twice daily (BID) for 1 year. Patients will be stratified according to CLL therapy and the number of prior NMSC. At the end of 1 year, patients will be unblinded, and all patients will receive Nicotinamide 500 mg BID for an additional year.

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?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Huntsman Cancer Institute

Collaborator

Trials

14

Recruited

7,700+

Published Research Related to This Trial

Oral niacin supplementation significantly reduces the incidence of skin cancer in mice exposed to UV radiation, with higher doses leading to greater reductions (from 68% in controls to 28% with 1.0% niacin).

Niacin enhances skin levels of NAD, which helps modulate important proteins involved in DNA damage response, and also prevents photoimmunosuppression, a key factor in UV-induced tumor formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral niacin prevents photocarcinogenesis and photoimmunosuppression in mice. Gensler, HL., Williams, T., Huang, AC., et al.[2021]

A systematic review of 29 trials involving 3039 patients found that oral nicotinamide significantly reduces the risk of skin cancers, including basal cell carcinomas (BCCs) and cutaneous squamous cell carcinomas (cSCCs), with a rate ratio of 0.50 compared to control.

While nicotinamide is effective in preventing skin cancers, it is associated with an increased risk of digestive adverse effects, suggesting that its use should be carefully considered, especially in healthy individuals or organ transplant recipients with a history of skin cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Nicotinamide in Skin Cancer and Actinic Keratoses Chemoprophylaxis, and Adverse Effects Related to Nicotinamide: A Systematic Review and Meta-Analysis. Mainville, L., Smilga, AS., Fortin, PR.[2023]

Topical nicotinamide (vitamin B-3) effectively prevented UVB-induced immunosuppression in mice, which is crucial for the development of skin tumors, by starting treatment two weeks before UV exposure.

In a study involving UV-irradiated mice, nicotinamide reduced the incidence of skin tumors from 75% to 42.5%, demonstrating its potential as a preventive treatment against photocarcinogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of photoimmunosuppression and photocarcinogenesis by topical nicotinamide. Gensler, HL.[2013]

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]

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]

A Phase 3 clinical trial showed that oral nicotinamide (NAM) is safe and effectively reduces the incidence of new non-melanoma skin cancers and actinic keratosis in high-risk individuals.

While NAM is recognized for its anti-aging properties and potential oncopreventive effects, the specific molecular and cellular mechanisms behind its ability to delay cancer development are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible mechanisms of cancer prevention by nicotinamide. Buqué, A., Bloy, N., Kroemer, G., et al.[2021]

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]

Citations

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

Nicotinamide for Skin Cancer Chemoprevention Overall, there was a significant 14% reduction in skin cancer risk. When nicotinamide was initiated after a first skin cancer, the risk ...

2. 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 54%, ...

3. foxnews.com foxnews.com/health/common-vitamin-shown-slash-skin-cancer-risk-some-groups-study-suggests

Vitamin B3 linked to lower skin cancer risk in new research ... New research shows that vitamin B3 (nicotinamide) reduced skin cancer risk by 14% among over 33000 veterans studied.

4. uspharmacist.com uspharmacist.com/article/less-risk-of-some-skin-cancers-with-otc-nicotinamide

Less Risk of Some Skin Cancers With OTC Nicotinamide “Overall, there was a significant 14% reduction in skin cancer risk,” the authors pointed out. “When nicotinamide was initiated after a first ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40960808/

Nicotinamide for Skin Cancer Chemoprevention Overall, there was a significant 14% reduction in skin cancer risk. When nicotinamide was initiated after a first skin cancer, the risk ...

6. ajmc.com ajmc.com/view/nicotinamide-reduces-new-skin-cancer-risk-in-large-veteran-study

Nicotinamide Reduces New Skin Cancer Risk in Large ... Oral nicotinamide reduced the risk of new skin cancers—especially squamous cell carcinoma—by up to 54% when started after a first diagnosis.

7. oncologyrepublic.com.au oncologyrepublic.com.au/vitamin-b3-reduces-rate-of-new-skin-cancers/5426

Vitamin B3 reduces rate of new skin cancers Now, a new study published in JAMA Dermatology suggests that nicotinamide use is associated with a reduced risk of developing skin cancer. “ ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1506197

A Phase 3 Randomized Trial of Nicotinamide for Skin ... Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients.

9. ascopost.com ascopost.com/news/september-2025/can-nicotinamide-lessen-the-risk-of-skin-cancer-development/

Can Nicotinamide Reduce the Risk of 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 54%, ...