Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients
Status:
Completed
Trial end date:
2020-12-18
Target enrollment:
Participant gender:
Summary
Skin cancers and pre-cancerous growths (called actinic keratoses, "AKs"), that aren't
melanomas, develop in patients with a kidney transplant at excessive rates. When these
pre-cancerous AKs, and "non-melanoma" skin cancers occur in kidney transplant patients, they
tend to be aggressive, and require frequent medical procedures, often surgery, for the
removal of the skin cancers. If not removed adequately the pre-cancers can develop into skin
cancers, and the skin cancers, if not removed, may spread, and even cause death. Reducing the
occurrence and complications of these skin cancers and pre-cancers in kidney transplant
patients with a safe, effective, well-tolerated treatment taken by mouth would be an
important medical advance.
We are testing oral nicotinamide (NAM)-a B-vitamin compound-for that purpose. Approximately
fifty kidney transplant patients who have had at least one non-melanoma skin cancer in the
past, will be given randomized to receive NAM, 1 gram twice daily by mouth, or identical
pills without NAM, and followed for 1 year to see if NAM treatment reduces the numbers of
pre-cancerous AKs, and non-melanoma skin cancers they develop. Patients will be asked to come
to the clinic for 3 follow up visits (every 4 months for up to 12 months). They will receive
a full body skin exam by a dermatologist, have detailed counting of AKs and biopsies for any
suspicious lesions as standard of care. Blood will also be drawn as well as a urine sample
obtained at each visit for safety assessment and storage. We will also ask them to answer a
series of questions about dietary patterns and intake of whole foods and supplements.