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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Photodynamic therapy (PDT)

Vitamin D3

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D3 + Photodynamic therapy (PDT)

Arm 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.

Outcomes

Primary Outcome Measures

Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months

Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment Baseline vitamin D (calcidiol) level will be taken for each patient.

Secondary Outcome Measures

Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK

Whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness (as measured by percent reduction in AK) to Vitamin D as a neoadjuvant for PDT.

Number of Participants Reporting 1 or Higher on the Pain Scale

Pain scale recorded on a 0-to-10 visual/analog scale, with higher scores mean more pain; 0 is no pain, 10 is "the worst pain imaginable". Number of participants receiving treatment that reported a pain level greater than 1.

Tolerability as Measured by Participants' Symptom Score Sheets

Participants are asked to recall the symptoms they experienced during the week following PDT. The study physician asks them whether they had experienced each of the following 13 symptoms (YES/NO), and positive (YES) answers were summed to create a Side Effects Score (SES). The maximum and minimum possible values are 13 and 0 respectively, with a higher score correlating to poorer participant outcomes. The 13 possible side effects were: pain, erythema, scabbing, blistering, erosions, edema, warmth, exfoliation, discharge, hemorrhage, tightness, hyperpigmentation, hypopigmentation.

Accumulation of Protoporphyrin IX (PpIX) Within AK

Accumulation of protoporphyrin IX (PpIX) within AK PpIX accumulation in areas of both actinic damage and normal skin will be measured with a fluorescence dosimeter. The level of calcidiol, a clinically accepted marker of vitamin D status, will be measured in each patient to see if supplementation with 10,000 IU of Vitamin D increase the accumulation

Full Information

NCT ID

NCT04140292

First Posted

October 24, 2019

Last Updated

June 1, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04140292

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

November 24, 2020 (Actual)

Study Completion Date

May 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 + Photodynamic therapy (PDT)

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Photodynamic therapy (PDT)

Intervention Description

PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered.

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Intervention Description

D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result

Primary Outcome Measure Information:

Title

Clinical PDT Response as Measured by Percent Change in AK Lesions From Baseline to 3 Months

Description

Clinical PDT response as measured by the percent change of AK lesions 3 months after treatment Baseline vitamin D (calcidiol) level will be taken for each patient.

Time Frame

3 months after treatment

Secondary Outcome Measure Information:

Title

Correlation Between Vitamin D Receptor (VDR) Polymorphisms and Percent Reduction in AK

Description

Whether gene polymorphisms in VDR and CYP27B1 are predictive for the degree of responsiveness (as measured by percent reduction in AK) to Vitamin D as a neoadjuvant for PDT.

Time Frame

3 months after treatment

Title

Number of Participants Reporting 1 or Higher on the Pain Scale

Description

Time Frame

During treatment (at the 5 min mark), and again immediately afterwards.

Title

Tolerability as Measured by Participants' Symptom Score Sheets

Description

Time Frame

1 week after treatment

Title

Accumulation of Protoporphyrin IX (PpIX) Within AK

Description

Time Frame

3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward V Maytin, MD, PhD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All IPD that underlie results in publication

Citations:

PubMed Identifier

35314199

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.

Results Reference

derived

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

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