Supplemental vitamin A and nicotinamide for kidney transplant recipients at high risk of skin cancer

Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide

This pilot will test whether taking oral nicotinamide and vitamin A is safe and doable for kidney transplant recipients who have had recent skin cancers.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rhode Island Hospital (Academic / other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT05702398 on ClinicalTrials.gov

What this trial studies

This early-phase pilot enrolls adult kidney transplant recipients with a recent history of multiple cutaneous squamous cell carcinomas or extensive treated premalignant lesions. Participants will take oral nicotinamide and vitamin A or a matching placebo while investigators monitor safety, tolerability, and adherence. The trial excludes people with significant liver disease, recent myocardial infarction, certain medication interactions, very low kidney function, pregnancy, or genetic skin cancer syndromes. Findings will provide preliminary safety and feasibility data to guide larger cancer prevention trials in this high-risk population.

Who should consider this trial

Good fit: Adults (18+) who have received a kidney transplant and have a recent history of multiple invasive cutaneous squamous cell carcinomas or extensive treated premalignant skin lesions are the intended participants.

Not a fit: People with active liver disease, recent myocardial infarction, eGFR <15 mL/min/1.73 m2, pregnancy or lactation, genetic skin cancer syndromes, very large numbers of current skin cancers, metastatic SCC or recent invasive melanoma, or those taking interacting drugs like carbamazepine are not likely to be eligible or benefit.

Why it matters

Potential benefit: If successful, the regimen could reduce future skin cancers in transplant recipients and support larger prevention trials.

How similar studies have performed: Oral nicotinamide has reduced new nonmelanoma skin cancers in other high-risk groups, but the combination with vitamin A in kidney transplant recipients is less well studied.

Eligibility criteria

Inclusion Criteria:

* 18 years old or greater;
* Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or
* At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);
* Understands, reads, and writes English proficiently.

Exclusion Criteria:

* Liver disease;
* Active peptic ulcer disease;
* Recent myocardial infarction;
* Hypotension;
* Internal malignancy within past 5 years;
* Renal impairment with eGFR\<15 mL/min/1.73 m2;
* Being unable for follow up due to social reasons;
* Gorlin's syndrome or other genetic skin cancer syndrome;
* Huge number of current skin cancers;
* Metastatic SCC or invasive melanoma within the past 5 years;
* Pregnancy or lactation;
* Need for ongoing carbamazepine use (which could have a possible interaction with NAM);
* Use of acitretin or other oral retinoids within the past 6 months;
* Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;
* Field treatment for actinic keratoses (AKs) within the previous 4 weeks;
* Use of topical steroids.

Where this trial is running

Providence, Rhode Island

• Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)

Study contacts

• Study coordinator: Eunyoung Cho, ScD

Conditions Skin Cancer; Kidney Transplant Recipients