Skin Cancer Clinical Trial
Official title:
Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Blood Vitamin A and Nicotinamide Levels | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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