Clinical trial NCT04140292: Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
Official title: Vitamin D Supplementation as a Neoadjuvant for Photodynamic Therapy of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study group will be compared to a baseline cohort of patients from a previous study (IRB 16-1615) who received the same regimen of PDT, but without any Vit D
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK
timeFrame: 3 months after treatment
measure: Number of Participants Reporting 1 or Higher on the Pain Scale
timeFrame: During treatment (at the 5 min mark), and again immediately afterwards.
measure: Tolerability as Measured by Participants' Symptom Score Sheets
timeFrame: 1 week after treatment
measure: Accumulation of Protoporphyrin IX (PpIX) Within AK
timeFrame: 3 months after treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Edward V Maytin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bullock TA, Negrey J, Hu B, Warren CB, Hasan T, Maytin EV. Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial. J Am Acad Dermatol. 2022 Jul;87(1):80-86. doi: 10.1016/j.jaad.2022.02.067. Epub 2022 Mar 18.