Vitamin D and light therapy to boost skin cancer response before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether pre-treatment with Vitamin D, with or without photodynamic therapy (PDT), enhances the immune response against nonmelanoma skin cancers in adults scheduled for Mohs surgery or ED&C. Participants are randomized to receive Vitamin D or placebo for six days and then undergo PDT within 1–14 days before surgery, with photographs and optional blood draws collected for research. Some participants may opt to proceed with surgery or ED&C without the PDT pre-treatment. The study explores the potential for PDT plus Vitamin D to improve tumor clearance and reduce visible scarring, addressing a gap in the approval and optimization of PDT for thicker skin cancers in the U.S.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must be an adult participant (\> 18 yrs) who is scheduled to undergo Mohs surgery or ED\&C within the Dermatologic Surgery unit of the Department of Dermatology, Cleveland Clinic.
* Must have at least one BCC or SCC tumor eligible for removal by Mohs surgery.
* The original tumor size prior to biopsy must be \>1.0 cm (in the longest diameter).
* Participants of any ethnic group are eligible for this trial.
* Must provide informed consent to participate in the trial.
* Participant must live in Ohio (Groups 2 \& 3), because Research Pharmacy cannot ship the study drugs outside of the state.

Exclusion Criteria:

* Pregnant or breastfeeding
* Currently being treated for other cancers with medical or radiation therapy
* Known hypersensitivity to 5-aminolevulinic acid
* History of a photosensitivity disease, e.g., porphyria cutanea tarda

Where it's running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Edward Maytin, MD, PhD — Case Comprehensive Cancer Center, Cleveland Clinic
• Study coordinator: Edward Maytin, MD, PhD
• Email: maytine@ccf.org
• Phone: (216) 346-6022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.