Calcium Electroporation for Head and Neck Cancer

2017-02-14 12:38:22 | BioPortfolio


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).


Calcium electroporation. Electroporation is a technique that facilitates the transport of molecules across the cell membrane by using electric pulses. The electric field applied to the cell membrane creates a temporary destabilization. As the electric capacity of the membrane is exceeded, cracks are formed in the membrane and the molecules are free to diffuse into the cytosol of the cell. The process is reversible and the cell membrane is stabilized in a matter of minutes. While the cell membrane is permeable there is an increased influx of Ca2+ into the cell. Calcium influx may be further improved by combining calcium together with electroporation; this is called calcium electroporation.

In vivo studies have shown that when enhancing the extracellular calcium concentration before applying electroporation, a larger Ca2+ influx occurs. The large Ca2+ influx can lead to a reduction in ATP (adenosine triphosphate) levels and cell death. A fall in ATP levels is seen for two reasons: First, an increase in intracellular Ca2+ leads to a higher activity of the Ca2+-ATPase and Na+/K+-ATPase. Secondly, the high concentration of Ca2+ leads to loss of the electrochemical gradient in the mitochondrial membrane, which causes mitochondrial collapse. Upon collapse of the mitochondria, the cell can no longer produce ATP. Overall, the increased consumption and decreased production of ATP leads to lover ATP levels. Combined with other cellular processes such as activation of lipases and proteases, the cell will eventually die.

Trials objectives.

1. Primary outcome. Evaluating the safety measures of using calcium electroporation on mucosal head and neck cancer. This is done by continuously evaluating pain by VAS-score (visual analogue scale) and side effects by Common Terminology Criteria for Adverse Events (CTCAE) registration into Adverse Events (AE) and Serious Adverse Events (SAE). The safety of using calcium intratumourally is also evaluated by measurement of Ca2+ in blood samples after treatment.

2. Secondary outcome. Evaluation of response by imaging: PET-MRI, Clinical photography, Biopsies from tumour site The subjects subjective evaluation of the treatment and post treatment period is evaluated through Quality of life questionnaires, EORTC QLQ-C30 and H&N35: two different questionnaires both validated for head and neck cancer patients.

3. Tertiary outcome. The response to treatment will be compared to the results from our current trial, where we use electrochemotherapy on mucosal head and neck tumours. The comparison will be between imaging response, VAS score and results from questionnaires (EORTC QLQ-C30 and H&N35).

Trial design. This is a phase I, interventional, clinical trial for the safety of calcium electroporation on mucosal head and neck tumours. Subjects will have relapsed or primary head and neck cancer. Treatment is intended as palliative and not curative. All subjects will be offered standard treatment with surgery and radiotherapy before enrolment to the trial, if possible. There is no scheduled control group, meaning that all eligible patients will be offered treatment.

Electroporation and anaesthesia. The treatment is performed under general anaesthesia because the localization of head and neck tumours complicates treatment under local anaesthetic. After the patient is anaesthetized, the tumour area will be injected with calcium. After administration of calcium electrodes are inserted into the tumour and electrical pulses are generated and documented using a Cliniporator (IGEA, Capri, Italy). Overall operating time/anaesthesia time will be 1-2 hours and expected hospital stay of 3 days. Treatment is intended as a once-only treatment but measurable response on evaluation scans combined with continued cancer activity in the treated area can result in another treatment session.

Study Design


Head Neck Cancer


Calcium chloride, Electroporation


Department of Otorhinolaryngology, Rigshospitalet, Copenhagen University Hospital




Rigshospitalet, Denmark

Results (where available)

View Results


Published on BioPortfolio: 2017-02-14T12:38:22-0500

Clinical Trials [2713 Associated Clinical Trials listed on BioPortfolio]

Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer

The purpose of the trial is to study the safety and efficacy of the Medpulser Electroporation System with bleomycin in the treatment of head and neck cancer.

Calcium Electroporation for the Treatment of Colorectal Cancer

In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Tavokinogene Telseplasmid With Electroporation, Pembrolizumab, and Epacadostat in Treating Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck

This phase II trial studies how well tavokinogene telseplasmid with electroporation, pembrolizumab, and epacadostat work in treating patients with squamous cell carcinoma of the head and n...

Calcium Electroporation for Early Colorectal Cancer

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation...

Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma

The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surge...

PubMed Articles [18623 Associated PubMed Articles listed on BioPortfolio]

Plasma circulating tumor DNA as a potential tool for disease monitoring in head and neck cancer.

Recommendations for perioperative therapy in head and neck cancer are not explicit and recurrence occurs frequently. Circulating tumor DNA is an emerging cancer biomarker, but has not been extensively...

Temporal Changes in Head and Neck Cancer Incidence in Thailand Suggest Changing Oropharyngeal Epidemiology in the Region.

Head and neck cancer is the sixth most common cancer in the world, and the largest burden occurs in developing countries. Although the primary risk factors have been well characterized, little is know...

A group intervention to promote work ability in patients with head and neck cancer.

Despite high distress the majority of head and neck cancer patients does not use any psycho-oncological counselling or psychotherapeutic support. Additionally, patients with head and neck cancer have ...

Head and Neck Masses.

Head and neck cancers comprise 4% of the cancer burden in the United States each year. Many types of head and neck cancers present as an asymptomatic, nontender neck mass or nonspecific symptoms, such...

Tobacco smoking, alcohol drinking, betel quid chewing, and the risk of head and neck cancer in an East Asian population.

The smoking prevalence among men in China is high, but the head and neck cancer incidence rates are low. This study's purpose was to investigate the impact of tobacco, betel quid, and alcohol on head ...

Medical and Biotech [MESH] Definitions

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

Dissection in the neck to remove all disease tissues including cervical LYMPH NODES and to leave an adequate margin of normal tissue. This type of surgery is usually used in tumors or cervical metastases in the head and neck. The prototype of neck dissection is the radical neck dissection described by Crile in 1906.

A form of RHABDOMYOSARCOMA arising primarily in the head and neck, especially the orbit, of children below the age of 10. The cells are smaller than those of other rhabdomyosarcomas and are of two basic cell types: spindle cells and round cells. This cancer is highly sensitive to chemotherapy and has a high cure rate with multi-modality therapy. (From Holland et al., Cancer Medicine, 3d ed, p2188)

A salt used to replenish calcium levels, as an acid-producing diuretic, and as an antidote for magnesium poisoning.

A symptom, not a disease, of a twisted neck. In most instances, the head is tipped toward one side and the chin rotated toward the other. The involuntary muscle contractions in the neck region of patients with torticollis can be due to congenital defects, trauma, inflammation, tumors, and neurological or other factors.

More From BioPortfolio on "Calcium Electroporation for Head and Neck Cancer"

Quick Search


Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...

Searches Linking to this Trial