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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: Eunyoung Cho, ScD
• Email: Eunyoung_Cho@brown.edu
• Phone: 401-863-5895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.