Clinical Trial in the Treatment of Peritoneal Carcinomatosis (Malignant Ascitis)

Ascitis maligna y OncothermiaClinical trial in the treatment of peritoneal carcinomatosis

Oncothermia and Traditional Chinese Medicine (TCM) versus Chemotherapy

Dr. Pang’s team, Clifford Hospital, Guangzhou, China, recently published in the Molecular Clinical Oncology journal (Mol Clin Oncol, 2017 May; 6 (5): 723-732) the results of the Phase II Clinical Trial on the complementary use of Oncothermia in Peritoneal Carcinomatosis with malignant Ascitis.

The purpose of this study was to develop a safe and non-toxic alternative to the conventional conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) by investigating the efficacy and safety of Oncothermia combined with the traditional Chinese medicine (TCM) ‘Shi Pi’ herbal decoction, compared with standard intraperitoneal chemoinfusion (IPCI).

A randomized, controlled, single-center, open-label clinical trial (phase II) with two parallel groups (allocation ratio, 1:1) was conducted to investigate the efficacy and safety of Oncothermia+TCM (study group, SG) vs. standard IPCI (control group, CG) in patients with PCMA by intention-to-treat analysis.

A total of 260 patients with PCMA were randomly allocated into the two groups (130/130); Oncothermia was applied for 60 min per session every second day for 4 weeks, for a total of 14 sessions. The TCM decoction was administered orally, at 400 ml daily. In CG, occlusive IPCI with cisplatin (30–60 mg) and fluorouracil (500–600 mg/m2) was applied twice, biweekly. The objective response rate (ORR), quality of life (QoL) and adverse event rate (AER) in the two groups were evaluated 1 month after treatment, analyzed and compared.

The present study is registered on ClinicalTrials.gov (NCT02638051). No case was lost or excluded (0/260).

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  • The ORR in SG was 77.69% (101/130) vs. 63.85% (73/130) in CG (P<0.05)
  • The QoL in SG was 49.23% vs. 32.3% in CG (P<0.05)
  • The AER in SG was 2.3% (3/130) vs. 12.3% (16/130) in CG (P<0.05)

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All the adverse events were grade I.

Results

The combination of Oncothermia with TCM achieves better control of PCMA compared with standard IPCI, with less toxicity.

Both components of the combination are non-toxic treatments easily tolerated by patients.

Thus, this combined treatment may be preferred due to the better benefit-harm balance.

If you wish to expand the information regarding Oncotermia applied to cancers, you can visit the following link.

Effect of Oncothermia at the cellular level. Study in colorectal cancer xenografts

Effect of Oncothermia at the cellular level. Study in colorectal cancer xenografts

Researchers studied the effect of Oncothermia at the cellular level in the process of apoptosis in colorectal cancer cells.

The Department of Radiology of the Medicine and Pharmacy Faculty -University of Toyama, in Toyama, Japan- published in the journal CellStress and Chaperones (Springer) (Cell Stress Chaperones, 2015 Jan; 20 (1): 37-46 ) the results on the effect of Oncothermia in colorectal cancer cells.

Cell apoptosis

First of all, the use of modulated electrohyperthermia (mEHT) or Oncothermia, produces a modification of the electric field and the surrounding temperature of the tumor cell, leading to selective cell death (apoptosis) in malignant tumors without affecting healthy tissue. Certainly, this is possible due to the difference of a tumor cell compared with a healthy cell. Also, the tumor cell is characterized by high glycolysis, increased lactate production (Warburg effect) and reduced electrical impedance.

Oncothermia applied to colorectal cancer

Dr Andocs studied the effect of Oncothermia on HT29 xenografts of colorectal cancer (human colon cancer cells, inoculated in mice). Apoptosis caused by Oncothermia was mediated, predominantly, by the caspase cascade and the activation of the apoptosis inducing factor. The mEHT-related cell stresses studied 0-, 1-, 4-, 8-, 14-, 24-, 48-, 72-, 120-, 168- and 216-h. And post-treatment by focusing on damage-associated molecular pattern (DAMP) signals.

 Apoptosis response was after 4 hours from the treatment with Oncothermia. It was measured using the levels of messenger RNA (mRNA) levels of the “heat shock” proteins Hsp70 and Hsp90.

Results

After that, the treatment resulted in spatiotemporal occurrence of a DAMP protein signal sequence featured by the significant cytoplasmic to cell membrane translocation of calreticulin at 4 h, Hsp70 between 14 and 24 h and Hsp90 between 24- and 216-h post-treatment.

Also, the release of high-mobility group box1 protein (HMGB1) from tumor cell nuclei from 24-h post-treatment and its clearance from tumor cells by 48 h was also detected.

Conclusion

In conclusion, the results suggest that mEHT treatment can induce a DAMP-related signal sequence in colorectal cancer xenografts that may be relevant for promoting immunological cell death response, which need to be further tested in immune-competent animals.

To conclude, the next experimental phase, which is to replicate the study in immunocompetent animals, is necessary.

Further information

If you would like further information on Oncothermia applied to colon cancer, please visit the following link.

Oncothermia and the use of oral transmucosal fentanyl citrate

Oncothermia and the use of oral transmucosal fentanyl citrate

Dr. Lee’s team, Department of Oncology, Institute of Clinical Medicine, Chonbuk University, Jeonju, Republic of Korea, published in the journal Clin Ther. 2016 Dec; 38 (12): 2548-2554, results on the safety of the use of Oncothermia and the drug for pain: transmucosal oral fentanyl citrate.

The purpose of this study was to determine if changes occur in the absorption and disposition of the drug fentanyl when it is administered together with the modulated electrohyperthermia treatment (mEHT, Oncothermia).

A randomized, single-dose, crossover, open-label study was used to investigate the effect of Oncothermia on the pharmacokinetic properties of fentanyl in 12 healthy volunteers.

Method

The 12 healthy volunteers were each administered a single dose of oral transmucosal fentanyl citrate (OTFC) or a single dose of OTFC with Oncothermia. Oncothermia was performed on the abdomen for 1 hour. Blood samples were collected for 24 hours after dosing. The temperature of the abdominal skin surface was assessed before dosing and at 10, 20, and 60 minutes after dosing.

Results

There was an increase in the overall exposure to the drug without implications of any clinical significance. OTFC can be administered without limitations in combination with Oncothermia, and it is not necessary to modify the dosing regimen.

For further information on Oncothermia, please visit the following link.

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Oncothermia at the Congress of Radiotherapy Technicians (10-12 / 11/2017, Lisbon, Portugal)

Oncothermia at the Congress of Radiotherapy Technicians (10-12 / 11/2017, Lisbon, Portugal)

Filipe Cidade de Moura and Prof.András Szász

Oncothermia is an adjuvant treatment for cancer. It is present at an international level at events such as this congress and other conferences. At these scientific meetings, doctors, technicians and healthcare personnel give presentations to disseminate the results of clinical cases.

Congress in Lisboa

Therefore, on November 10-12, 2017, in Lisbon, took place the Congress of Radiotherapy Technicians (Congresso 2017art).

The congress was organized in different sections. Professor Szasz led the talk “Immunological effects with Oncothermia“, where he presented his latest research and results. Also, he detailed his studies on Oncothermia and the results in relation to the inhibitory effect on the natural activity of the malignant cells. Among other things he highlighted the stimulation of the patient’s immune response.

Objective of the research

Most of the radiation therapies act locally. The local control of the tumor is usually not enough for elongation of the survival time because the malignancy is systemic. The abscopal effect, together with immune-stimuli could extend the local method to systemic and could be effective against macro- and micrometastases, too. Our objective is presenting the abscopal effect of modulated electro-hyperthermia (mEHT, oncothermia).

References

https://www.justnews.pt/documentos/2015/image/file/17e/ProgramaCNART-2017.pdf

http://oncotherm.com/en/news-events/congresso-2017-art-profandras-szasz-was-invited-hold-lecture

Oncothermia combined with chemotherapy for the treatment of recurrent cervical cancer

Oncothermia combined with chemotherapy for the treatment of recurrent cervical cancer

Researchers compared the effect of Oncothermia combined with conventional chemotherapy versus chemotherapy alone in patients with cervical cancer.

Cáncer cérvix Oncothermia

Dr. Lee’s team, from Department of Radiation Oncology, Institute of Medical Sciences, Chonbuk Medical University, South Korea, has recently published in the journal Oncology Letters the results on the complementary use of Oncothermia in recurrent Cervix Cancer previously treated with radiotherapy.

The present study was performed to evaluate the effect of Oncothermia combined with conventional chemotherapy compared with chemotherapy alone on recurrent cervical cancer previously treated with irradiation.

Method

A total of 20 patients, aged 36-71 years, with cervical cancer were treated with chemotherapy. Of these, 18 patients were treated with chemotherapy combined with Oncothermia. In addition, the equipment used was: EHY2000 (Oncotherm GmbH, Troisdorf, Germany). And the frequency was 13.56 MHz, with the circular electrode diameter of 30 cm.

In addition, local metastases (including para-aortic lymph nodes and adjacent pelvic lymph nodes) were considered in the inclusion criteria of the study. Also, patients with distant metastases were excluded.

For the study, Oncothermia was applied 3 times a week for 60 minutes from the start of chemotherapy. A total of 36 sessions were carried out.

Results

The overall response (complete remission + partial remission + stable disease/progressive disease) to treatment was significantly greater in the group of patients who underwent chemotherapy combined with Oncothermia (P=0.0461). Then, Oncothermia was shown to be more effective in the treatment of local metastases (lymph nodes). No complications with the use of Oncothermia were reported.

Conclusion

In conclusion, in patients with recurrent cervical cancer treated with radiotherapy, the overall response rate to treatment is significantly higher in patients who combined chemotherapy with Oncothermia compared to those who only received chemotherapy.

Reference

Lee SY, Lee NR, Cho DH, Kim JS. Treatment outcome analysis of chemotherapy combined with modulated electro-hyperthermia compared with chemotherapy alone for recurrent cervical cancer, following irradiation. Oncol Lett. 2017 Jul;14(1):73-78. doi: 10.3892/ol.2017.6117. Epub 2017 May 4. PMID: 28693137; PMCID: PMC5494813.

Retrospective study of Oncothermia combined with chemotherapy for the treatment of Glioblastoma. Efficiency and cost-effectiveness analysis

Retrospective study of Oncothermia combined with chemotherapy for the treatment of Glioblastoma. Efficiency and cost-effectiveness analysis

Dr. Roussakow`s Team, Department Galenic Research Institute, Moscow, Russia, recently published in the Biomedical Journal Open (BMJ Open, 2017 Nov 3; 7 (11)) the results on the complementary use of Oncothermia in Glioblastoma multiform.

Researchers compared the efficacy and cost-effectiveness of Oncothermia (electrohyperthermia mEHT) with chemotherapy (temozolomide, ddTMZ) versus chemotherapy alone in a patient with recurrent Glioblastoma multiforme (GBM).

This is a retrospective study of a population of 54 patients diagnosed with recurrent Glioblastoma multiforme treated with chemotherapy and Oncothermia (ddTMZ + mEHT) during the period 2000-2005. The comparison was made with a population of 114 patients, diagnosed with GBM, treated with chemotherapy alone (ddTMZ) during the period 2008-2013.

Results:

The treatment effect analysis (ETA) suggests that Oncothermia significantly improves the survival of patients receiving oral chemotherapy (ddTMZ). Economic evaluation suggests that ddTMZ+Oncothermia is cost-effective, budget-saving and profitable. It is derived from the results that Oncothermia can be recommended for the treatment of recurrent Glioblastoma multiforme. Oncothermia can even be assessed as monotherapy as a rescue treatment when chemotherapy fails.

Synergy of Oncothermia with Vitamin C in the treatment of lung cancer

Dr Ou’s team, from Cancer Center, Clifford Hospital, Guangzhou, University of Medicine, China, published in the journal Eur J Pharm Sci. 2017 Nov 15; 109: 412-418, results on the synergy of intravenous Vitamin C and Oncothermia.

Vitamin C intravenously (VitC) and Oncothermia (electrohyperthermia modulated (mEHT)) have been used in medical centers for integrative medicine for the treatment of cancer, for many years. However, no pharmacokinetic study had been planned to assess Chinese cancer patients.

A clinical trial was conducted to evaluate safety and pharmacokinetics in patients with stage III-IV non-small cell lung cancer (NSCLC). A total of 35 patients with lung cancer (NSCLC) were included. A total of 15 patients with stage III-IV who entered the phase I study were selected. They were randomized allocated into 3 groups, and received doses 1.0, 1.2, 1.5 g/kg AA infusions. Participants in the first group received intravenous AA (IVAA) when mEHT was finished, in the second group IVAA was administered simultaneously with mEHT and in the third group IVAA was applied first, and followed with mEHT. The process was applied 3 times a week (every other day, weekend days off) for 4 weeks. We found that fasting plasma AA levels were significantly correlated with stage of the disease. Peak concentration of AA was significantly higher in the simultaneous treatments than in other combinations with mEHT or in solely IVAA-managed groups. 

Results:

IVAA synergy with simultaneous mEHT is safe. The concomitant application significantly increases the plasma AA level for NSCLC patients wiht non-small cell lung cancer (NSCLC).

Oncothermia Barcelona unit: latest generation model EHY-2000 plus

Oncothermia is a method of non-invasive modulated electromagnetic hyperthermia, complementary in the treatment against cancer, which promotes a natural regulatory process of the body. The brand Oncotherm® was founded in 1988 by Professor Dr. András Szász, as an initiative for the development and research of the electro-hyperthermia method in the treatment of cancer.

Treatment with Oncothermia started in Germany 25 years ago, and is currently used in more than 25 countries. Only in Germany is it in 4 hospitals and in more than 50 clinics functioning effectively. Every year more than 100,000 annual treatments are carried out worldwide

At the Oncothermia Barcelona Unit is the latest generation model: EHY-2000 plus, the latest technology to offer the best results

Modelo EHY-2000 de Oncothermia

About Oncothermia:

  • Oncothermia is active in all solid tumors.
  • No side effects, rare contraindications.
  • Energy absorption combined with modulated electric field.
  • Tumor tissue is treated selectively by destroying only the malignant tissue
  • Healthy tissue is not affected.
  • The effectiveness of chemotherapy and radiotherapy improves with treatment.
  • Restores intercellular junctions, suppresses dissemination (metastasis).
  • Oncothermia induces immunogenic cell death.
  • It improves the quality of life, reduces the side effects of other treatments.
  • A proven method for 30 years with more than 100,000 treatments per year.

Oncothermia in brain tumors

Prof. Giammaria Fiorentini of the Department of Onco-Hematology of Azienda Ospedaliera Marche Nord, Pesaro, Italy, presented at the 35th Annual Conference of the International Clinical Hyperthermia Society (ICHS) in Guangzhou, the results of their work in the treatment with Hyperthermia (Oncothermia) in patients with brain tumors.

The study was carried out with an Oncotherm EHY-2000 PLUS device, on 24 patients: 19 with glioblastoma multiforme and 5 with astrocytoma. All of them were previously treated with surgery, TMZ chemotherapy and radiotherapy.

Through the article Prof. Giammaria Fiorentini describes the characteristics of brain tumors, their incidence and mortality, survival and conventional therapies that are used, with an emphasis on the case of Glioblastoma and the benefits obtained by applying Electro-hyperthermia.

According to his observations Oncothermia (Electro-hyperthermia) is a non-invasive treatment, without toxicity and feasible to treat recurrent malignant gliomas, which allows to increase the response to the tumor and the survival of the patient.

The full article can be accessed by visiting this link.

Hypothesis: Studies that observe the effectiveness of Hyperthermia in HG Gliomas.

Oncothermia (Electro – Hyperthermia) traslational studies.

Oncothermia application in malignant gliomas.

Study on the activity and toxicity of Oncothermia in recurrent malignant gliomas.

Description of the equipment used: Oncotherm EHY-2000 PLUS, non-ionizing therapy that elevates the temperature of the tumor macro and micro-enviroments, to a range of 40-45ºC, generating a 40-150 Watt radiofrequency, at 13.56 MHz.

24 patients, 19 with glioblastoma multiforme and 5 with astrocytoma. All patient were pre-treated with surgery, chemotherapy and radiotherapy.

Oncothermia treatment: 3 sessions/week for 4 weeks, 20 a 60 minutes each session.

Results: 2 complete remissions and 5 partial remissions were observed. The medial OS was 14 months for gliomas and 61 months for astrocitomas.

Conclussions:

– Oncothermia applicated in patients with relapsed malignant gliomas is feasible and may increase tumor response and survival.

– EHT is a non-invasive method to treat malignant gliomas without toxicity.

– EHT appears to have effectiveness and further studies are warranted.

– EHT can be considered a landmark stone of integrative oncology.

Source:

Fiorentini G. (2018): Oncothermia in brain tumours; Oncothermia Journal 22: 151-177

www.oncothermia- journal.com/journal/2018/Oncothermia_in_brain_tumours.pdf

Chemotherapy and Oncothermia association

Chemotherapy and Oncothermia association

Lower and less toxic doses of chemotherapy by combining it with Oncothermia and complementary treatments.

Modelo EHY-2000 de Oncothermia

Professor Dr. med. Alexander Herzog, Chief-physician, Fachklinik Dr. Herzog, Germany has published a recent clinical study in the Oncothermia journal. He also presented it at the 35th ICHS, Guangzhou, China, 2017. The study explains the results in the use of lower and less toxic doses of chemotherapy when combined with hyperthermia and complementary treatments.

Electro-hyperthermia (Oncothermia) is an important tool for improving the efficacy of chemotherapy and radiation in cancer.

Numerous studies have been published on Oncothermia treatment in cell cultures, in animal experiments, but also in patients. Furthermore, these studies include randomised studies, phase 2 studies, but also many successful case reports that provide evidence for the benefit of Oncothermia.

Methods:

Oncothermy means heating the cancerous tissue up to 42°C (107.6°F). In several experiments, it has been shown that chemotherapy works more efficiently if the temperature of the cancer tissue is increased. There can be a linear or even exponential increase in the activity of cytostatic drugs.

The Oncotherm device with 13.56 MHz and energies up to 150 watts was used. The local treatment takes 1 hour for each session. In addition, such treatment can be repeated frequently (the interval between 2 treatments should be at least 48 hours to avoid thermal tolerance).

Chemotherapy is administered simultaneously with a local Oncothermia session.

Results for a selection of different cancers:

♦ ENT-Cancers:

The standard chemotherapy in these cases would be a rather toxic 5-day programme of cisplatin together with 5-FU as a continuous infusion. Together with oncothermia, a 4-day programme would be sufficient.

♦ Non-small cell lung cancer:

The dosing regimen would follow platinum-based chemotherapy, but the doses of Carboplatin and Gemcitabine or Vinorelbine could be reduced by approximately 20%, if applied together with Oncothermia.

♦ Colorectal cancer:

Chemotherapy protocols in colorectal cancer are mainly the FOLFOX protocol and the Folfiri protocol, which can be combined with Bevacizumab or Cetuximab antibodies. Together with Oncothermia, the dose of Oxaliplatin would be kept at the standard level. Irinotecan could be reduced. 5-FU administered as a chronomodulated treatment at night with 50% of the dose between 2 a.m. and 6 a.m. could also be significantly reduced. In addition, Capecitabine can be used together with Oncothermia at a reduced dose.

♦ Ovarian and cervical cancers:

In ovarian and cervical cancer, the standard chemotherapy is Carboplatin and the neurotoxic drug Paclitaxel. Together with Oncothermia, Carboplatin could be combined with a less toxic dose of Cyclophosphamide, which is a drug with potentiation of its activity under hyperthermic conditions.

♦ Breast cancer:

In one study, it has been shown that 70-80% of breast cancer patients respond to a treatment programme with local oncothermia together with moderate doses of chemotherapy.

Reduces toxicity

In conjunction with oncothermia, it is possible to use chemotherapy in more moderate doses. This reduces toxicity. Above all, it helps patients in particular in the palliative situation to preserve quality of life. It also allows for more regular treatments and for a longer period of time which is possibly very important to improve survival times.

Sources:

Herzog A. (2018): Lower and less toxic doses of chemotherapy by combining it with hyperthermia and complementary treatments; Oncothermia Journal 22:46-56