Vitamin D + PDT for Skin Cancer

Overseen By Edward Maytin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Pregnant, Breastfeeding, Other cancers, Photosensitivity, others

Compensation: Varies

Number of Visits: 2

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how photodynamic therapy (PDT), combined with Vitamin D, affects the immune response to nonmelanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma. Participants will receive either Vitamin D or a placebo before their PDT treatment and subsequent skin cancer surgery. This study is ideal for individuals in Ohio scheduled for Mohs surgery or ED&C to remove skin tumors larger than 1.0 cm in diameter. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future skin cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Vitamin D, when combined with light-based treatment (PDT), is generally safe and well-tolerated. One study found that a high dose of Vitamin D is safe and enhances PDT's effectiveness in treating skin cancer, such as squamous cell carcinoma. Additionally, Vitamin D can boost PDT's effectiveness for non-melanoma skin cancers.

Evidence also suggests that Vitamin D enhances PDT's ability to kill cancer cells. This combination has been studied for its potential to improve cancer treatment. Based on these findings, both Vitamin D and PDT appear safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Vitamin D with Photodynamic Therapy (PDT) for skin cancer because it targets cancer cells in a potentially more effective and less invasive way. Unlike standard treatments like surgery or radiation, PDT uses light-sensitive drugs and a light source to destroy cancer cells with minimal damage to surrounding tissue. The addition of Vitamin D might enhance this process by boosting the immune response and improving skin health, which could lead to better outcomes and faster recovery times. This combination could offer a promising alternative for patients seeking less aggressive treatments with fewer side effects.

What evidence suggests that this trial's treatments could be effective for nonmelanoma skin cancer?

Research has shown that using Vitamin D with photodynamic therapy (PDT) can enhance treatment effectiveness for nonmelanoma skin cancers. One study found that taking Vitamin D before PDT improved treatment response by 18%. Another study demonstrated that Vitamin D helped clear up squamous cell carcinoma, a type of skin cancer. In experiments with mice, high doses of Vitamin D combined with PDT led to better results for skin cancer treatment. In this trial, one group of participants will receive Vitamin D before PDT, while another group will receive a placebo before PDT. These findings suggest that Vitamin D might enhance the effects of PDT in treating skin cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Edward Maytin, MD, PhD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with nonmelanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) who are scheduled for Mohs surgery or ED&C. Participants will be randomly assigned to receive Vitamin D or a placebo, in addition to undergoing photodynamic therapy before their standard treatment.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive Vitamin D or placebo for 6 days and undergo a single PDT treatment 1-14 days prior to their surgery

2-3 weeks

1 visit (in-person) for PDT treatment

Surgery and Data Collection

Participants undergo Mohs surgery or ED&C, and data is collected from tissue samples

Up to Day 20

1 visit (in-person) for surgery

Follow-up

Participants are monitored for immune response and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photodynamic Therapy (PDT)
• Vitamin D

Trial Overview The study aims to evaluate the effects of Vitamin D supplementation and photodynamic therapy on the immune response against skin cancer. Patients will take Vitamin D or a placebo for six days and have one PDT session before their planned surgery.

How Is the Trial Designed?

Group I: Arm 2: VitD + PDT prior to Mohs surgery or ED&C Experimental Treatment 3 Interventions

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

Group II: Arm 1: Participants donate discarded tissue for research (No VitD/Placebo + no PDT) Experimental Treatment 1 Intervention

Participants in Arm 1 will donate discarded tissue from their scheduled standard of care Mohs surgery or ED\&C. They will not be randomized to receive VitD or placebo and will not have PDT.

Group III: Arm 3: Placebo + PDT prior to Mohs surgery or ED&C Placebo Group 3 Interventions

Participants in Arms 2 and 3 will be randomized to receive either VitD or placebo prior to PDT and Mohs surgery or ED\&C visit.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9502525/

Vitamin D and Vitamin D3 Supplementation during ... Oral vitamin D3 therapy before PDT led to an 18% increase in response to treatment. An increase in the effectiveness of the therapy (by 11%) in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025002364

High-dose oral vitamin D in combination with ... As one example, high-dose Vitamin D (VD) was shown to be a safe and effective neoadjuvant for PDT to improve the resolution of cutaneous squamous cell carcinoma ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07241585

Vitamin D Effects on Immune Microenvironment of ... This research study explores the effect of photodynamic therapy (PDT) on nonmelanoma skin cancers (NMSC). NMSC are made up of basal cell ...

4. jaad.org jaad.org/article/S0190-9622(22)00481-9/abstract

Significant improvement of facial actinic keratoses after ... In mouse models of skin cancer, high-dose oral vitamin D3 (VD3; cholecalciferol) combined with photodynamic therapy (PDT) can improve the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S157210002400022X

Combination of vitamin D and photodynamic therapy ... Improved treatment outcomes for non-melanoma skin cancers can be achieved if Vitamin D (Vit D) is used as a neoadjuvant prior to photodynamic therapy (PDT).

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/php.70008

Immunomodulatory effects of photodynamic therapy for ... In this review, we highlight basic and translational studies on effects that locally administered PDT exerts on the immune system.