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

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

January 6, 2023

Study Completion Date

January 6, 2023

Conditions
Basal Cell CarcinomaBasal Cell Nevus Syndrome
Interventions
DRUG

Dietary Vitamin D3 pre-treatment

The daily dose of D3 will always be 10,000 IU/day. Total amounts of D3 supplementation given will be adjusted, based upon serum 25-hydroxy-D3 levels found at baseline. Duration of pretreatment will be 14 days if the D3 level is \< 31 ng/mL, and 5 days if the D3 level is \> 31 ng/mL

RADIATION

Photodynamic therapy

Photodynamic Therapy (PDT) is an experimental technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells.

DRUG

Serum Maintenance Vitamin D3

2,000 IU/d for adults, 1,000 IU/d for children taken after third visit.

Trial Locations (2)

44195

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland

85006

Medical Dermatology Specialists Phoenix, Phoenix

All Listed Sponsors
lead

Case Comprehensive Cancer Center

OTHER

NCT03467789 - Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma | Biotech Hunter | Biotech Hunter