RECRUITINGEarly Phase 1INTERVENTIONAL
Pilot Trial of Supplemental Vitamin A and Nicotinamide
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 18 years old or greater;
- Either History of 2 or more diagnosed by tissue sample (biopsy-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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Vitamin A
1,000 μg retinyl palmitate twice a day for 6 months
DRUG
Nicotinamide
500 mg NAM twice a day for 6 months
OTHER
Other: Placebo
Identical placebo pills twice a day
Locations (1)
Rhode Island Hospital
Providence, Rhode Island, United States