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The Effect of Reduced Bleomycin in Electrochemotherapy Treatment

NCT06647342 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-01-23

No results posted yet for this study

Summary

The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors.

Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively.

Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.

Conditions

  • Cutaneous Metastasis
  • Cutaneous Malignant Mixed Tumor
  • Bleomycin Adverse Reaction
  • Electrochemotherapy

Interventions

DRUG

Bleomycin

In the standard arm, Bleomycin (Baxter, Germany) at a dose of 15.000 IU/m² is used. In the dose reduction arm, a dose of 7500 IU/m² is used. Note that in Denmark bleomycin is dosed by international units, whereas other countries may use respectively U (units) or mg.

Sponsors & Collaborators

  • Roskilde University

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Julie Gehl

    lead OTHER

Principal Investigators

  • Julie Gehl, Professor, MD · Department of Oncology and Palliative Care, Zealand University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647342 on ClinicalTrials.gov