- Abstract viewed - 233 times
- PDF downloaded - 136 times
Affiliations
Ioana Cosgarea
Dermatological Sciences, Institute of Cellular Medicine, United Kingdom
Yuri Chemale
Esteio Primary Care Centre José Mario de Carvalho (Tamandaré) Rio Grande do Sul, Brazil
Khalid Ahmed
Hamad Medical Corporation, Doha, Qatar
Muhammed Enes Gunduz
Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Harvard Medical school, Spaulding Rehabilitation Hospital, Boston, MA.
Julia Rodriguez
Knowledge Management and Epidemiology Director at CEDIMAT, Danto Domingo, Dominican Republic
Juanita Rodriguez
Beth Israel Deaconess Medical Center, Harvard Affiliated Hospital, Boston, Massachusetts
Lerro Leonardo
Centro Universitário Lusíada (UNILUS), Santos, São Paulo, Brazil
Julia de Oliveira
Clinica AMO – Assistência Multidisciplinar em Oncologia, Salvador, Bahia, Brazil
Denise Schwartz
Department of Internal Medicine. School of Veterinary Medicine and Animal Science. University of Sao Paulo Brazil
Arturo Tamayo
Section Neurology, Department of Medicine. Max Rady Faculty of Medicine. University of Manitoba. Health Sciences Centre. Winnipeg Canada and Brandon HSC. Canada.
Anjali Dhawan
Neonatologist, Newborn Care Unit, Blacktown Hospital, NSW, Australia
Belkis Mejia
Essen Medical, Bronx, New York, USA
Louisa Schonhaut
Clinica Alemana, FAcultad de Medicina, Universidad del Desarrollo, Santiago, Chile
Victoria Olvera
Clínica del Dolor del Bajío, Apaseo el Alto, Gto. Mexico
Talmas Fernandes
Clínica Reunidas São Victor, Rio de Janeiro, Rio de Janeiro, Brazil
Felipe Coimbra
Surgical Oncology Division, Department of Abdominal Surgery, AC Camargo Cancer Center, São Paulo, SP, Brazil
Valmir Crestani
Kidney Transplant Unity, Department of Urology. University of Sao Paulo -Brazil
Flavio Machado
Universidade Estadual de Feira de Santana - UEFS, Department of Health, Collegiate of Medicine. Feira de Santana, Bahia, Brazil
Paula Guimaraes
Ophthalmology Department, Hospital Evangelico de Belo Horizonte, AEBMG. Belo Horizonte, MG, Brazil
Georgiana Constantinescu
Department of Medicine III, University Hospital Carl Gustav Carus,Technische Universität Dresden, 01307 Dresden, Germany
Vitamin D Supplementation to Prevent Redevelopment of Basal Cell Carcinoma (BCC): A Phase III Randomized Clinical Trial Protocol
- Ioana Cosgarea ,
- Yuri Chemale ,
- Khalid Ahmed ,
- Muhammed Enes Gunduz ,
- Julia Rodriguez ,
- Juanita Rodriguez ,
- Lerro Leonardo ,
- Julia de Oliveira ,
- Denise Schwartz ,
- Arturo Tamayo ,
- Anjali Dhawan ,
- Belkis Mejia ,
- Louisa Schonhaut ,
- Victoria Olvera ,
- Talmas Fernandes ,
- Felipe Coimbra ,
- Valmir Crestani ,
- Flavio Machado ,
- Paula Guimaraes ,
- Georgiana Constantinescu
Vol 5 No 1 (2019): Principles and Practice of Clinical Research
Submitted: Jan 11, 2019
Published: Jul 5, 2019
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.