Clinical trial · Interventional
The Effect of Reduced Bleomycin in Electrochemotherapy Treatment
Randomised Controlled Clinical Trial Investigating the Effect of Reduced Bleomycin in Elechtrochemotherapy Treatment on Patients With Cutaneous Malignancies (The BLESS Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleomycin Adverse Reaction | — | UNRESOLVED | — |
| Cutaneous Malignant Mixed Tumor | Malignant Mixed Tumor of the Skin | ALIAS | 0.90 |
| Cutaneous Metastasis | Skin Neoplasm | PROBABILISTIC | 0.70 |
| Electrochemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard dose
- description
- Patients in this arm will recieve the standard dose of bleomycin during treatment with electrochemotherapy
- interventionNames
- Drug: Bleomycin
- type
- EXPERIMENTAL
- label
- Dose reduction
- description
- Patients in this arm will recieve half the standard dose of bleomycin during treatment with electrochemotherapy
- interventionNames
- Drug: Bleomycin
Primary outcomes (1)
- measure
- To evaluate the clinical overall response rate of electrochemotherapy treatment of cutaneous malignancies after three months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Trial subject \> 18 years. 2. Trial subject must be able to understand the participant information. 3. Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. 4. Life expectancy \> 3 months. 5. Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study. 6. Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed. 7. Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed. 8. A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance \> 50 ml/min. 9. Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization. 10. Signed informed consent. Exclusion Criteria: 1. Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment. 2. Allergy or hypersensitivity to bleomycin. 3. Acute lung infection. 4. Severely impaired lung function or any lung condition the investigator deems severe. 5. Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit. 6. The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose.
References
Publications (1)
- BACKGROUNDBastrup FA, Vissing M, Gehl J. Electrochemotherapy for metastatic cutaneous melanoma. Acta Oncol. 2022 May;61(5):531-532. doi: 10.1080/0284186X.2022.2057199. Epub 2022 Apr 29. No abstract available. PMID 35484987