Vitamin D Supplementation to Prevent Redevelopment of Basal Cell Carcinoma (BCC): A Phase III Randomized Clinical Trial Protocol

Abstract

Introduction: Basal cell carcinoma (BCC) is the most common non-melanoma skin cancer and a serious disease leading to increased morbidity and high medical costs worldwide. Despite the high recurrence rate of BCCs, the current standard of care consists of regular skin check-ups, with no know therapy to prevent the recurrence. Vitamin D is a safe, affordable, and easily available supplement used for various diseases. There is evidence suggesting its potential use in preventing BCCs, with studies showing that it inhibits the Hedgehog (HH) signaling pathway, an important stimulator of carcinogenesis and the main pathway in BCC development. The objective of this study is to determine the effect of oral vitamin D supplementation on the prevention of BCC redevelopment.

Methods: This study is a phase III, multicenter, randomized, placebo-controlled, triple-blinded, superiority trial with two parallel groups on 1:1 allocation of 1746 patients with a previous diagnosis of BCC. The patients will either receive 1000 IU of Vitamin D daily or placebo.  During the three-year follow-up period, patients will be undergoing skin check-ups every six months, with laboratorial tests annually. The primary endpoint will be the development of further BCC during 3 years after the initiation of vitamin D supplementation. The statistical analysis will be a time-to-event approach.

Discussion:This is a triple-blinded, randomized, placebo-controlled trial for prevention of a highly prevalent condition. Vitamin D would be a simple solution to prevent the development of further basal cell carcinoma, having tremendous positive effect not only by improving the quality of life of patients, but also by reducing the financial burden on health care systems.