Pilot Trial of Supplemental Vitamin A and Nicotinamide

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 [niacin]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island Hospital
• Treatments: Niacin; Niacinamide; Nicotinic Acids; Vitamin A; Vitamins

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.