The evaluation of new therapeutic resources against coronavirus disease 2019 (COVID‐19) represents a priority in clinical research considering the minimal options currently available. To evaluate the adjuvant use of systemic oxygen‐ozone administration in the early control of disease progression in patients with COVID‐19 pneumonia. PROBIOZOVID is an ongoing, interventional, randomized, prospective, and double‐arm trial enrolling patient with COVID‐19 pneumonia. From a total of 85 patients screened, 28 were recruited. Patients were randomly divided into ozone‐autohemotherapy group (14) and control group (14). The procedure consisted in a daily double‐treatment with systemic Oxygen–ozone administration for 7 days. All patients were treated with ad interim best available therapy. The primary outcome was delta in the number of patients requiring orotracheal‐intubation despite treatment. Secondary outcome was the difference of mortality between the two groups. Moreover, hematological parameters were compared before and after treatment. No differences in the characteristics between groups were observed at baseline. As a preliminary report we have observed that one patient for each group needed intubation and was transferred to ITU. No deaths were observed at 7–14 days of follow up. Thirty‐day mortality was 8.3% for ozone group and 10% for controls. Ozone therapy did not significantly influence inflammation markers, hematology profile, and lymphocyte subpopulations of patients treated. Ozone therapy had an impact on the need for the ventilatory support, although did not reach statistical significance. Finally, no adverse events related to the use of ozone‐autohemotherapy were reported. Preliminary results, although not showing statistically significant benefits of ozone on COVID‐19, did not report any toxicity.
Matrix-producing breast cancer (MPC) is a subtype of metaplastic carcinoma of the breast. It is a very rare tumor, which constitutes less than 1% of all malignant mammary tumors. The origin of this tumor is still unclear: there are molecular studies that suggest an origin from myoepithelial cells, whereas other studies underline the neoplastic transformation of a multipotent stem cell. Even the differential diagnosis of MPC and other breast neoplasms (phyllodes tumors and real sarcomas of the breast) is not always easy. In the literature, a certain chemoresistance has been demonstrated, and a standard treatment of this tumor does not exist at this time. We report the case of a 44-year-old, premenopausal, female patient with a 6-cm breast lump. Neither imaging nor fine needle aspiration biopsy was crucial in achieving a diagnosis. The patient underwent a simple mastectomy. In consideration of the negative lymph node status, the patient was not subjected to radiotherapy or adjuvant chemotherapy. Moreover, since the receptor status was negative, hormone therapy was not necessary. The patient has been disease free for 4 years now.
In this paper we report the clinical case of a 84 year old female patient with a history of breast cancer diagnosed 14 years before, treated only with hormone therapy for 10 years and with subsequent follow-up oncology which always demonstrated negative results. 14 years after the first diagnosis, the patient presented with an increase in mass markers (CEA), and progressive symptoms of the right eye (diplopia). A CT scan and an MRI of the orbits confirmed the presence of an expansive neoplastic formation of the right orbit of 16 × 9 mm. The orbital metastases are rare locations of metastatic breast cancer which pose problems of differential diagnosis and require prompt and multimodal treatment (chemotherapy, hormone therapy, radiation therapy) aimed at improving the quality of life of the patient.
BACKGROUND: Our group in Policlinic Umberto I - University Hospital of Sapienza Rome - has decided to further investigate if Ozone therapy can be of support in oncology. In literature it has been reported that ozone applications in oncology or in cancer cells is associated with: high efficiency in preventing chemotherapy complications (nausea, vomiting, opportunistic infections, asthenia) as well as confining or restricting the expansion of tumours.(1-5) PURPOSE: The aim of our study in to evaluate and eventually confirm the validity of ozone treatments in order to consider such procedures as a possible and concrete support therapy for oncology patients undertaking chemotherapy. A statistical significance and clinical evaluation of our work would finally give a scientifically validation, still missing, to officially consider ozone therapy as one of the many possible integrative therapy in oncology. DESIGN: It is a pilot study designed and approved by the Ethical Committee of the University of Rome, La Sapienza (March 2017) to evaluate quality of life and reduction of side effects of adjuvant chemotherapy in 20 breast cancer patients. METHODS: The selected patients will be treated with systemic ozone treatment: Ozonated autohemotherapy will be performed according to the following method: 200 ml venous blood will be exposed an equal amount of O2 /O3 (200 ml) The ozone concentration will be gradually increased as follows: 20-30-40 mcrg/mL with a specific schedule until each patient will receive 15 applications overall. The sessions will be scheduled according to a specific timetable during the administration of adjuvant chemotherapy by means of Epirubicin and Cyclophsphamide (EC) every 3 weeks for 4 cycles followed by Paclitaxel for 12 consecutive weeks. Ozone therapy will not be applied on days of chemotherapy in order to avoid interaction between chemotherapeutics and ozonides. Biochemical blood analysis and stress oxidative blood test will be used as parameters for activity of antioxidant defence system. Quality of life will be evaluated with Fact G Test. It is the first study to have been evaluated and approved by an official university ethical committee and we will be glad to publish our result as soon as possible. On this behalf it would be great if any other centre could be interested in cooperating with us so to transform this pilot study into a multicentre study with larger numbers and therefore, with a greater impact on the international community. Our aim is to give cancer patients a better life quality in general and especially help them overcome all the side effects during the chemotherapy. This could open a new scenario in the alternative complementary treatments in oncology.
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