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NCT05702398 | Not yet recruiting | Skin Cancer

Pilot Trial of Supplemental Vitamin A and Nicotinamide
Sponsor:

Rhode Island Hospital

Brief 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.

Condition or disease

Skin Cancer

Kidney Transplant Recipients

Intervention/treatment

Vitamin A

Nicotinamide

Other: Placebo

Phase

Early Phase 1

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Quadruple
Primary Purpose : Basic Science
Official Title : Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023
Arm Intervention/treatment

Experimental: Vitamin A & Nicotinamide

1,000 μg retinyl palmitate and 500 mg NAM twice a day

Drug: Vitamin A

Placebo Comparator: Placebo

Identical placebo pills twice a day

Drug: Nicotinamide
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Pilot Trial of Supplemental Vitamin A and Nicotinamide

Location Details

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Pilot Trial of Supplemental Vitamin A and Nicotinamide

How to Participate

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