drugset / Trial / NCT03467789

Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma

NCT03467789

Phase 1 Completed 37 enrolled Case Comprehensive Cancer Center
RandomizedCrossoverTriple-blindTreatment

Summary

The purpose of this study is to study 50 patients with multiple Basal Cell Carcinoma (BCC) who will be receiving Photodynamic Therapy (PDT) as treatment for their tumors. This study wants to establish the optimal conditions for treating BCC tumors with PDT. Previous research suggests that taking Vitamin D prior to the start of PDT could help improve the effectiveness of the treatment in eliminating the BCC. Overall, this study will help establish oral Vitamin D3/PDT as a new combination therapy for skin cancer (BCC). Photodynamic Therapy (PDT) is an investigational (experimental) technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells. PDT is currently approved for the treatment of BCC in Europe, Canada, and Australia. However, it is experimental in the United States because it is not approved by the Food and Drug Administration (FDA).

Timeline

Start
2018-10-01
Primary completion
2023-01-06
Completion
2023-01-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 1000 iu Oral
Subject Cholecalciferol Other / unclassified 2000 iu Oral