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Study on Blood Vessel Changes in Basal Cell Carcinoma Patients Treated with Bleomycin or Drug Combination

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What is this study about?

This clinical trial focuses on studying changes in blood vessels in a common type of skin cancer known as basal cell carcinoma. The study will explore two non-surgical treatments: electrochemotherapy and photodynamic therapy. Electrochemotherapy involves using electrical pulses to help a drug, in this case, bleomycin, enter cancer cells more effectively. Photodynamic therapy uses a special light along with a drug to kill cancer cells. The main goal of the study is to observe how these treatments affect the small blood vessels in the cancerous area using a technique called optical coherence tomography (OCT), which is a non-invasive imaging method that provides detailed pictures of tissues.

Participants in the study will undergo either electrochemotherapy or photodynamic therapy. Throughout the study, the changes in the blood vessels will be monitored at different depths of the skin before and after the treatment. This will help researchers understand how the treatments work on a microscopic level. Additionally, the study will look at factors like the thickness and density of the cancer, as well as any side effects such as skin darkening, to see how they might influence the treatment outcomes. The quality of life of participants will also be assessed to understand the impact of these treatments on their daily lives.

The study aims to provide valuable insights into the effectiveness of these non-surgical treatments for basal cell carcinoma and to identify any predictors of successful treatment outcomes. By understanding the changes in blood vessels and other factors, researchers hope to improve treatment strategies for this common skin cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination by a dermatological specialist.

A punch biopsy is performed to confirm the diagnosis of basal cell carcinoma (BCC) on the trunk or extremities, with a diameter less than 2 cm.

2 treatment selection

The treatment involves either electrochemotherapy or photodynamic therapy. The choice of treatment is determined based on specific criteria and the patient’s condition.

3 bleomycin application

For patients undergoing electrochemotherapy, bleomycin is applied to the skin. This medication is used to treat the cancerous area and is administered through cutaneous use.

4 treatment sessions

Treatment sessions are scheduled according to the study protocol. The frequency and duration of these sessions depend on the specific treatment plan assigned to the patient.

5 monitoring and assessment

Throughout the trial, the microvascular changes in the BCC are monitored using a technique called dynamic optical coherence tomography (D-OCT).

Assessments are conducted at various depths (0, 150, 300, and 500 micrometers) to evaluate changes in blood vessels before and after treatment.

6 follow-up evaluations

Follow-up evaluations are performed to assess the clinical outcome and any side effects, such as hyperpigmentation due to bleomycin.

Quality of life is also evaluated using a specific questionnaire designed for this purpose.

7 final assessment

A final assessment is conducted at the end of the study period to determine the overall effectiveness of the treatment and any long-term effects.

Who Can Join the Study?

  • Patients must be mentally capable of understanding the information given.
  • Patients must give written informed consent, which means they agree to participate after understanding the study details.
  • Patients must have a clinically diagnosed low-risk basal cell carcinoma (BCC) on the trunk and extremities, with a size less than 2 cm. Basal cell carcinoma is a type of skin cancer.
  • Participants must be men or women aged at least 18 years.
  • Cases must be reviewed by a dermatological specialist, a doctor who specializes in skin conditions.
  • Patients must be classified as ASA class I-III, which is a system used by the American Society of Anesthesiology to assess the fitness of patients before surgery.
  • Patients must have no prior history of sensitivity or allergies to the chosen treatment drug.
  • Patients must initially agree to have a punch biopsy performed at a 1-year follow-up. A punch biopsy is a procedure where a small piece of skin is removed for testing.
  • A female of non-childbearing potential is eligible if she:
    • Has had a hysterectomy, which is the removal of the uterus.
    • Has had a bilateral oophorectomy (ovariotomy), which is the removal of both ovaries.
    • Has had a bilateral tubal ligation, which is a procedure to block the fallopian tubes.
    • Is post-menopausal, meaning she has not had a menstrual period for over a year and is over 45 years old, or has specific hormone levels if there is any doubt.
  • A female of childbearing potential is eligible if she has had a negative pregnancy test within 2 weeks before the treatment.
  • Women of childbearing potential and men are eligible if they agree to use adequate contraception from the time they sign the consent form until at least 6 months after the last treatment cycle.

Who Cannot Join the Study?

  • Patients who have other types of skin cancer besides basal cell carcinoma cannot participate. Basal cell carcinoma is a common type of skin cancer.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible to join the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not allowed to participate.

Where you can join this trial?

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Site Name City Country Status
Region Sjaelland Holbæk Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.01.2025

Trial locations

Investigated drugs:

Electrochemotherapy is a treatment that combines chemotherapy with electrical pulses. The electrical pulses help the chemotherapy drugs enter cancer cells more effectively. This therapy is used to treat basal cell carcinoma by targeting and destroying cancer cells while minimizing damage to surrounding healthy tissue.

Photodynamic Therapy involves using a special drug that becomes active when exposed to a specific type of light. This activated drug then kills cancer cells. In the trial, photodynamic therapy is used to treat basal cell carcinoma by applying the drug to the skin and then shining a light on the area to activate the drug, which helps to destroy the cancer cells.

Investigated diseases:

Basal Cell Carcinoma – Basal cell carcinoma is a type of skin cancer that begins in the basal cells, which are found in the outer layer of the skin. It often appears as a slightly transparent bump on the skin, though it can take other forms. This cancer typically develops on areas of the skin that are exposed to the sun, such as the head and neck. It tends to grow slowly and is unlikely to spread to other parts of the body. Over time, it can cause significant damage to the surrounding tissue if not treated. The progression of basal cell carcinoma is usually localized, affecting only the area where it started.

Trial ID:
2024-518228-63-01
Trial Phase:
Therapeutic exploratory (Phase II)

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