Clinical trial · Interventional
Calcium Electroporation for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In a phase I protocol to primarily investigate the safety of using calcium combined with electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation, biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ C-30 and H\&N35 (european organisation for research and treatment of cancer).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head Neck Cancer | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium chloride | Drug | — | UNRESOLVED |
| Electroporation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- calcium chloride
- description
- Only one arm. All 6 enrolled patients are treated with calcium electroporation.
- interventionNames
- Drug: Calcium chloride
- Device: Electroporation
Primary outcomes (2)
- measure
- Change in Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- CTCAE are evaluated at several timepoints: 1) Baseline (before treatment). 2) 30 minutes and 6 hours after treatment. 3) Once at day 1, 2 and 3 after treatment. 4) 1 week after treatment. 5) 2 weeks after treatment. 6) 1 and 2 months after treatment.
- description
- Evaluated by change in CTCAE (common terminology criteria for adverse events) at different timepoints.
- measure
- Change in Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Subject age \> 18 years.
2. Verified cancer in the head and neck region of any histology.
3. At least one tumour lesion should be accessible for electroporation.
4. Performance status WHO \<= 2.
5. Progressive and/or metastatic disease.
6. Expected survival of \> 3 months.
7. A treatment-free interval of more than 4 weeks since chemotherapy or radiation therapy of the treatment area.
8. The subject should have been offered the current standard treatment. If there is no further standard treatment to offer or if the subject does not want to receive the treatments offered, the subject may be included in the trial.
9. The subject should be able to understand the information for participants and be willing and able to comply with hospitalization and the agreed follow-up visits and tests.
10. Platelets ≥ 50 billion/L, INR(international normalized ratio)\> 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
11. Sexually active men and women who can become pregnant must use adequate contraception during this trial (pill, spiral, injection of prolonged progestin, subdermal implantation, hormone-containing vaginal devices, transdermal patches).
12. Signed informed consent.
\-
Exclusion Criteria:
Patients should be excluded if they meet just one of the criteria stated below:
1. Symptomatic progression of the subject's cancer disease that requires another intervention.
2. Allergy to constituents of the planned anesthesia.
3. Coagulation disorder that cannot be corrected.
4. Chronic renal dysfunction with creatinine\> 200 mmol/L will trigger a Cr-51-EDTA (Ethylenediaminetetraacetic acid) clearance.
5. Pregnancy or lactation.
6. If participating in other clinical trials involving experimental drugs or involved in a trial within 4 weeks prior to study drug administration.
7. Other disorders investigator finds incompatible with participation in the trial.
\-References
Publications (4)
- BACKGROUNDFrandsen SK, Gibot L, Madi M, Gehl J, Rols MP. Calcium Electroporation: Evidence for Differential Effects in Normal and Malignant Cell Lines, Evaluated in a 3D Spheroid Model. PLoS One. 2015 Dec 3;10(12):e0144028. doi: 10.1371/journal.pone.0144028. eCollection 2015. PMID 26633834
- BACKGROUNDHansen EL, Sozer EB, Romeo S, Frandsen SK, Vernier PT, Gehl J. Dose-dependent ATP depletion and cancer cell death following calcium electroporation, relative effect of calcium concentration and electric field strength. PLoS One. 2015 Apr 8;10(4):e0122973. doi: 10.1371/journal.pone.0122973. eCollection 2015. PMID 25853661
- BACKGROUNDFrandsen SK, Gissel H, Hojman P, Tramm T, Eriksen J, Gehl J. Direct therapeutic applications of calcium electroporation to effectively induce tumor necrosis. Cancer Res. 2012 Mar 15;72(6):1336-41. doi: 10.1158/0008-5472.CAN-11-3782. Epub 2012 Jan 26. PMID 22282658
- BACKGROUNDPlaschke CC, Gothelf A, Gehl J, Wessel I. Electrochemotherapy of mucosal head and neck tumors: a systematic review. Acta Oncol. 2016 Nov;55(11):1266-1272. doi: 10.1080/0284186X.2016.1207803. Epub 2016 Oct 5. PMID 27705053