What is
Thermal Therapy?

Thermal therapy is a medical option for cancer treatment which increases the patient’s body temperature with the aim to boost the immune system, inhibit tumor growth and increase the sensitivity of other anticancer treatments.

Thermal therapy is toxic for cells in a hypoxic and low pH environment, conditions which are found specifically within tumor tissue, due to insufficient blood perfusion1.

Consequently, an anticancer effect can be obtained within the fever range with minimal injury to normal cells1,2. Leveraging these effects, thermal therapy increases the patient’s body temperature by applying heat externally in a controlled and precise manner.

Thermal Therapy supports other cancer therapies in different ways:
  • By activating the immune cells. Heat has a potential to boost the person’s immune system to help fight cancer. Recent research has identified complex effects of temperature on immune cells which may enhance immune surveillance 3–7 .
  • By shrinking tumors. High temperatures also have a direct cytotoxic effect by inducing necrosis and apoptosis 8,9.
  • By enhancing the efficacy of chemotherapy. Heat increases permeabilization and the blood flow in the stroma of the tumor, enhancing the oxidative stress (damage) of cancer cells10 and the resorption of anticancer drugs into cancer cells2,11,12. Chemotherapy thereby becomes more effective without further toxic effect to the patient2,13,14. This has been demonstrated in many recent positive phase III clinical trials for cancer 15–18.
  • By damaging radio-resistant cancer cells. Heat inhibits the recovery of cancer cells from DNA damage and acts on cancer cells that are resistant to radiation19. Hence, radiotherapy and thermal therapy are complementary in their action: free radicals are formed from radiotherapy, which damage the DNA of the tumor cells, and thermal therapy inhibits its reparation later on 19,20.
  • By enhancing radiotherapy efficacy. Thermal therapy increases the sensitivity of cancer cells to radiation19,21,22 by 1.5–5 times 23. Since thermal therapy augment the radiotherapy effect, its dose may be reduced to ease their side-effects without reducing its therapeutic effects. Clinical trials of combination of thermal and radiation therapy, showed that thermal therapy enhance radiotherapy efficacy 24–27.
  • By decreasing pain and improving quality of life. Thermal therapy may also significantly reduce pain during treatments, which may thus improve the quality of the patient’s life. This effect has been observed, among others, in clinical trials in humans with metastases 25,28.
References

Supporting pancreatic
cancer treatment

The additional effect of thermal therapy to standard of care treatment (such as chemotherapy and radiotherapy) has been shown in patients diagnosed with pancreatic cancer.

These curves show the percentage of people who did not have new tumor growth or cancer spread during or after treatment (progression-free survival) with CRHT (chemoradiotherapy-hyperthermia) in comparison to that of patients who underwent chemoradiotherapy (CRT) alone.

Adding thermal therapy to the treatment regime of chemoradiotherapy increased the disease progression-free survival of patients from 4.9 to 8.8 months. Their overall survival increased from 9.6 to 18.6 months (Ohguri et al, 2008, Tobata Hospital, Japan).

Overall, 14 clinical trials included 395 patients with locally advanced and/or metastatic pancreatic cancer of whom 248 received thermal therapy. The response rate reported in three trials with a control group, was better for the hyperthermia groups compared to the control group (chemotherapy and/or radiotherapy)(43.9% vs. 35.3%) (van der Horst et al, 2017, Amsterdam, The Netherlands).

Preclinical Studies

ElmediX has developed a highly accurate and sensitive systemic thermal therapy for therapeutic intervention. The device is designed to be safe and efficient as a anticancer treatment. Promising preclinical data demonstrates the safety and efficacy of this method in CAM and animal models, therefore a first-in-human clinical trial has been initiated.
Minipigs

Healthy minipigs have been used to prove the technical feasibility and safety of thermal therapy. The pig is one of the most frequently used large animal models in biomedical research due to its anatomical and physiological similarity to humans. Evaluation of the treated animals revealed some changes in biochemical blood parameters, but none of them was considered clinically significant. The animals remained healthy throughout the whole procedure and follow-up period.

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Dogs

After having proven the safety in healthy minipigs, the treatment was tested in a population of elderly dog patients with advanced or metastatic cancer. Dogs form an ideal model for cancer in humans because of histological, genetical and environmental similarities. Dogs with advanced and/or metastatic cancer were treated with thermal therapy in combination with a reduced standard of care treatment. The evolution of their clinical parameters indicated the safety of the treatment and the improvement of their Quality of Life.