30 Participants NeededMy employer runs this trial

Vitamin A + Nicotinamide for Skin Cancer

EC
Overseen ByEunyoung Cho, ScD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and feasibility of using nicotinamide (a form of vitamin B3) and vitamin A to help prevent skin cancer in individuals who have had kidney transplants. The researchers aim to determine if these vitamins benefit those at high risk due to a history of skin cancer. Participants will receive either the vitamin combination or a placebo (a pill with no active ingredients). Individuals who have had at least two skin cancers in the past two years and can read English are suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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

Research has shown that nicotinamide, a type of vitamin B3, is generally safe for people at high risk of skin cancer. One study found that participants taking nicotinamide had 14% fewer new cases of non-melanoma skin cancer, and they reported no serious side effects. This indicates that nicotinamide is usually well-tolerated.

Vitamin A is also part of the treatment being tested. Although excessive vitamin A can cause side effects, the amount used in studies like this one is typically safe. The safety of using nicotinamide and vitamin A together is still under investigation, particularly in groups like kidney transplant recipients. However, evidence so far suggests that these treatments are generally well-tolerated in similar groups.12345

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

Researchers are excited about using Vitamin A and Nicotinamide for skin cancer because these treatments take a novel approach. Unlike traditional methods like surgery, chemotherapy, or topical creams that often target existing cancer cells, Nicotinamide, a form of Vitamin B3, may help prevent DNA damage caused by UV exposure, reducing the risk of new skin cancers forming. Meanwhile, Vitamin A, particularly in the form of retinyl palmitate, is known for its potential in promoting healthy skin cell growth and repair. This combination could offer a preventive strategy, addressing skin cancer at the source before it develops, which is a significant shift from merely treating it after it appears.

What evidence suggests that this treatment might be an effective treatment for skin cancer?

Research has shown that nicotinamide, a type of vitamin B3, can help lower the risk of developing new skin cancers. Specifically, taking 500 mg of nicotinamide twice a day has been associated with a 14% reduction in overall skin cancer risk. For individuals with a history of skin cancer, this risk reduction can reach up to 54%. These findings suggest that nicotinamide may help prevent new cases of nonmelanoma skin cancers, particularly in high-risk individuals. While there is less direct evidence about the effectiveness of vitamin A in this area, it is often studied for its potential skin health benefits. This trial investigates the combined effects of Vitamin A and Nicotinamide on reducing skin cancer risk.13567

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.
Understands, reads, and writes English proficiently
I have had at least 2 invasive skin squamous cell cancers in the past 2 years or one procedure to remove 15 or more skin lesions.

Exclusion Criteria

Being unable for follow up due to social reasons
I have liver disease.
I currently have an active peptic ulcer.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1,000 μg retinyl palmitate and 500 mg NAM twice a day or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nicotinamide
  • Vitamin A

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin A & NicotinamideExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group1 Intervention

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

🇺🇸
Approved in United States as Nicotinamide for:
🇪🇺
Approved in European Union as Nicotinamide for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Citations

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.

VA Study Validates Vitamin B3 In Skin Cancer Prevention

"Not only did we find an overall 14% reduced risk of developing new skin cancers…but we also discovered that patients who started nicotinamide ...

Study reveals efficacy of nicotinamide for skin cancer prevention

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%, ...

4.

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 ...

Vitamin B3 May Reduce Non-Melanoma Skin Cancer Risk ...

Researchers found that taking 500 milligrams of nicotinamide twice daily led to an overall 14% risk reduction in two different types of skin ...

Skin Cancer and Vitamins: In Theory and Practise

Vitamin deficiency increases the risk for the primary development of skin cancer. Supplementation of certain vitamins supports conventional drug ...

Oncologists May Not Know Commonly Used Supplement ...

Popular anti-aging supplements composed of niacin (vitamin B3) derivatives may boost tumor growth and enhance chemotherapy resistance, ...