Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma (NCT03467789) | Clinical Trial Compass
CompletedPhase 1
Vitamin D as a Nutritional Neoadjuvant During Photodynamic Therapy of Basal Cell Carcinoma
United States37 participantsStarted 2018-10-01
Plain-language 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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Basal Cell Nevus Syndrome (BCNS) as defined in the Consensus Statement from the first International colloquium on BCNS.
* Major Criteria are:
* (1) BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type;
* (2) keratocyst of the jaw prior to age 20;
* (3) palmar or plantar pitting;
* (4) lamellar calcification of the falx cerebri;
* (5) medulloblastoma;
* (6) first degree relative with BCNS;
* (7) Patched-1 (PTCH1) gene mutation.
* Minor Criteria are:
* (1) rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals;
* (2) macrocephaly;
* (3) cleft/lip or palate;
* (4) fibroma of the heart or ovary;
* (5) ocular abnormalities;
* For diagnosis of BCNS, the participant must have either 2 major criteria, one major and two minor criteria.
* At least three BCC tumors, two of which are biopsy-proven
* Female subjects must not become pregnant during the study
* Subjects must be able to understand and willing to sign a written informed consent document
Exclusion Criteria:
* Pregnant or nursing.
* At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
* Taking vismodegib or a hedgehog pathway inhibitor; must stop at least 3 months prior to visit 1.
* Taking any topical treatment on their BCC tumors; must stop at least 1 month prior.
* Taking Vitamin D or multivitamin supplements; must st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
BCC: Rate of tumor clearance
Timeframe: Up to 6 months after first treatment visit