Purchasing of the ALBA Hyperthermia System for the Radiation Oncology Department of S. Camillo Medical Hospital, Rome

Project location: Italy, Rome
Project start date: July 2009 - Project end date: This project covers various years
Project number: 2009-12
Beneficiary: ASPRO Onlus

 [2013-013]

Hyperthermia therapy has been, since a long time, used as a support of traditional radiotherapy and chemotherapy, and in combination of both.

Radiation therapy is in itself painless, but the therapy causes varying side effects during treatment, in the months or years following treatment or after re-treatment as acute. Typical side effects are chronic pain, damage to the epithelial surfaces, swelling, infertility, fibrosis, hair loss, dryness, fatigue and secondary malignancies. Most side effects are predictable and expected. The aims of modern radiotherapy are to decrease nanoresistance and increase radiosensitivity, to reduce side effects to a minimum and to help the patient to understand and to deal with those side effects which are unavoidable. Furthermore the palliative treatments may be used to alleviate the side effects of curative treatments and increasing greatly patient's quality of life, especially for terminal malignancies.
Combining these therapies can increase the extent of short and long term success of an anticancer therapy. It has also been observed that hyperthermia allows clinicians to reduce doses of anticancer drugs and radiations administered to patients. Reducing doses helps, of course, reducing side effects of the anticancer therapy. Safety of hyperthermia treatment has been demonstrated. In vivo studies have demonstrated that the effect of radiotherapy can be enhanced by a factor of 1.2 to 5.
Other of this, the hyperthermia provided an efficient, effective means on pain relief of treating unresectable and recurrent cancer. The duration of pain relief can be prolonged, if an adequate heating is achieved. This happens because hyperthermia increases the circulating levels of several essential regulatory hormones as β-endorphin, prolactin, ACTH and cortisol.

In 2009 the Nando Peretti Foundation awarded a grant to ASPRO Onlus to equip the Radiation Oncology Department of S. Camillo Medical Hospital of Rome with the only portable CE-certified hyperthermia equipment in the world for oncological clinical application, designed to satisfy the clinical and the time/cost needs of today's oncological field and dedicated to improve the superficial and loco regional hyperthermia treatments in order to reach Radiotherapy and Chemotherapy standards.

This device uses the frequency of 434 MHz, an optimal frequency for the breast and superficial and semideep cancers treatment, and it ist he only one that has an integrated ultrasound system that improves the treatment quality.
The chosen device is built in Italy by a company active for 12 years in the clinical hyperthermia systems research and development, both for oncological and not oncological uses, and that has more than 180 installations in Italy, England, Spain, Holland and Japan. The oncological product is called ALBA Hyperthermia System mod. ON 4000 and is produced in the new high-tech district of Rome: Polo Tecnologico Tiburtino.
The system allows the real time ultrasound image view of the district been treated, the power data, the superficial and the cancer real time temperature and is also able to evaluate and modify the VAS scale, which quantifies the amount of pain perceived by the patient during the treatment. The software allows real-time monitoring, recording all data in a patient database, it allows also the transfer of the obtained data for subsequent studies useful for clinical improvements and the system can be connected via internet for real time technical assistance.
It should also be noted that the manufacturer company has been chosen as the supplier of two clinical and researchers Dutch groups, leaders on the world in the hyperthermia oncology, the Radiation Oncology Department of the Erasmus Medical Centre of Rotterdam and the Academic Medical Centre of Amsterdam.

The NPF contribution was therefore meant to:

- Donate the ALBA Hyperthermia System to the Radiation Oncology Department of S.Camillo, for the combined superficial and semi-deep cancers treatment and palliative care for the pain relief of patients with terminal malignancies.
- Create and disseminate studies and protocols that could assure specific national standard protocol treatments for the hyperthermial combined therapy.

Following the purchase of the Hyperthermia device, in 2010 Nando Peretti Foundation renewed its support to Aspro Onlus to extend and to standardize hyperthermia treatments to patients with breast cancer and chest wall recurrences by increasing the hyperthermia unit staff working in the Radiotherapy Department.

In consideration of the Oncological Hyperthermia Service offered by the San Camillo-Forlanini Hospital, thanks to the contribution of the Nando Peretti Foundation, having seen the effectiveness of treatments already achieved with this method and the increasing number of patients who come to the San Camillo-Forlanini Hospital to perform this kind of treatment, together with the traditional therapies, it became necessary to improve the existing staff adding two technicians into the hyperthermia unit of the radiotherapy department, with the purpose to create an excellence in the breast cancer and chest wall recurrencies treatment.

More specifically, the NPF contribution was meant to guarantee the presence of:

1. A new radiotherapist medical technician, qualified to perform oncological hyperthermia. The radiotherapist medical technician is the medical operator qualified to perform all the kind of therapies that needs ionizing artificial or natural radiations, thermal energies, ultrasonic sources;
2. A biomedical engineer in charge to integrate the hyperthermia treatment with the traditional therapies performing specific treatment planning systems to prepare, check, evaluate and register the hyperthermia treatment session and to collect the data to optimize the hyperthermia treatment for follow-up studies.

The ultimate project's goals are:
- to increase and improve the hyperthermia unit in the Radiotherapy Department Staff;
- to create an educational school for hyperthermia clinical technicians;
- to create a reference hyperthermia Italian and international center for the clinical treatment of oncological patients.

The ASPRO organization originated from the need of the radiotherapy patients to have bureaucratic, organizational and clinical support for the facilities provided by the Law for the Protection of the Rights of the Sick. It's the reference point for any needs that the patient may experience during the radiotherapy treatment. It is in close contact with other health organizations, the Court of Human Rights of the Sick and public facilities, URP, and in connection with the Ombudsman of the City of Rome.
The organization directs and helps the patient to fulfill the necessary bureaucratic activities in order to obtain the legal dispensations, such as request of civilian disability certificates, or or free circulation or parking permits. It also helps organizing the transportation for the Radiotherapy Centre in cooperation with Township, Town hall, the Provinces, House of volunteers, and it takes care of CAD and ADI assistance. The organization inserts the invalid patient in a specific route and activates the Welfare hotel for the support to non resident or indigent patients. In the cases of illness in terminal phase, they activate the procedures for the insertion in an appropriate environment, like the Hospice or the Domiciliary assistance. It provides essential support and every other organizational or residential information for best quality of life of the patient and his/her relatives, including instruments to improve the patient and his family's quality of life.
In this way, the organization has identified a device useful to improve both the pain relief of terminal patients and the therapeutic response to the radiotherapy treatment.

This project recived its third year of funding by the NPF in 2013.