Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Vitamin D3; Drug: Photodynamic therapy (PDT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04140292

CASE5619

Details and patient eligibility

About

This study is open to individuals with Actinic Keratoses (skin lesions that have the potential to turn into skin cancer), who are receiving photodynamic therapy (PDT) as part of their clinical care. The purpose of this study is to test and demonstrate that vitamin D pre-treatment can enhance PDT efficacy in the treatment of Actinic Keratoses.

Participants will be asked to take vitamin D supplements prior to their standard of care PDT treatment.

Participation in the research will last about 3-4 months.

Full description

The primary objective of this study is to determine whether acute supplementation (neoadjuvant Vitamin D3), adjusted according to baseline Vitamin D status, can improve the clinical PDT response relative to participants receiving PDT alone

The secondary objective of this study is to determine whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness to Vitamin D as a neoadjuvant for PDT.

This study is a non-randomized interventional trial, in which the study group will be compared to a baseline cohort of patients from a previous study who received the same regimen of PDT, but without any Vit D. It is anticipated that 30 participants will be involved in this study.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Actinic keratoses in sufficient numbers (>10) to warrant PDT therapy in the clinic

• Able to understand and willing to sign a written informed consent document

• Female subjects must not become pregnant during the study:

  • The effects of 5-aminolevulinic acid (LevulanTM) on the human fetus are unknown. For this reason, women of child-bearing potential must agree to use contraception (double barrier method of birth control or abstinence) prior to study entry, and throughout study participation. Should a woman become pregnant or suspect that she is pregnant while she is participating in this study, she should inform the treating physician immediately.

Exclusion criteria

• Pregnant or nursing.
• At risk for hypercalcemia (renal disease, sarcoidosis, etc.)
• Using topical retinoids, since these can exacerbate the post-PDT erythema reaction.
• Using any topical treatment on their AKs; must stop at least one month prior.
• Currently undergoing treatment for other cancers with medical or radiation therapy.
• Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
• Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.
• Currently participating in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Vitamin D3 + Photodynamic therapy (PDT)

Experimental group

Description:

Patients receive Vitamin D3 10,000 IU daily for 5 or 14 days depending on VitD baseline level. They then undergo Photodynamic therapy (PDT) for treatment of actinic keratosis.

Treatment:

Drug: Photodynamic therapy (PDT)

Drug: Vitamin D3