INFORMATION FOR PATIENTS

On June 30th 2000 the „Von Ardenne Clinic for systemic Cancer Multistep Therapy“ in Dresden successfully finished its work. Details can be found in the statement from April 14th 2000. Over a time period of ten years more than 1,000 patients in an advanced stage of cancer were treated with the systemic Cancer Multistep Therapy developed by Prof. Manfred von Ardenne. Prof. von Ardenne is considered to be a pioneer of oncological whole-body hyperthermia in Germany.

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With this brochure we would like to introduce the systemic Cancer Multistep Therapy to patients. The procedure of systemic Cancer Multistep Therapy in the former „Von Ardenne Clinic“ will be explained in here. Further information and the basics of systemic Cancer Multistep Therapy were published in German 1997 in the scientific monograph „systemische Krebs-Mehrschritt-Therapie“ (available under ISBN 3-773-1297-5).

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1. What is systemic Cancer Multistep Therapy?
The systemic Cancer Multistep Therapy (sCMT) is a combined modality treatment for malignant tumors of the mammary gland, of the gastric intestinal tract, of the lungs, of the urogenital tract, of the skin, bones and soft-tissues as well as some select hematological diseases. In principle, adenocarcinoma and squamous epithelium carcinoma with or without metastases, osteosarcoma and soft-tissue sarcoma of nearly all localizations, the malignant melanoma and non-Hodgkin lymphoma and also chronic lymphatic leucemia can be treated.

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The systemic Cancer Multistep Therapy consists of a frame treatment and the sCMT main treatment proper.

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The frame treatment is pre- and post positioned, comprises an Oxygen Multistep Immunostimulation Therapy of a maximum of 18 days and is carried out on an ambulatory basis. The sCMT main treatment, which lasts several hours, is followed by at least 24 hours of stationary post-treatment of the patient.

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By means of the interaction of the therapy steps consisting of infrared-A whole-body hyperthermia (artificial warming-up), induced hyperglycemia (artificially increasing the glucose level), relative hyperoxemia (oxygen enrichment of the blood) and, if prearranged with the patient, modified chemotherapy, there exists the chance of a positive influencing on the course of disease even for tumors which previously responded neither to radiotherapy nor to cytostatics nor to hormones.

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2. How does systemic Cancer Multistep Therapy work?
Cancer tissues accumulate lactic acid at an extremely increased glucose level because cancer cells metabolize glucose to a great extent into lactic acid, even in the presence of oxygen. This overacidification makes the cancer cells more sensitive to hyperthermia, whereas the other normal cells are stabilized energetically by the glucose in the presence of oxygen. In a temperature range between 41.5 and 42.5 °C (106.7…108.5 °F), the cancer cells are in this way destroyed or at least damaged and the normal tissues of the organism are not affected. The increased oxygen content in the blood results in a stabilization of the functions of all life-essential organs. Because of the systemic character of sCMT and the detected overacidification of metastasis down until a volume of about 1 mm³, the sCMT is directed especially to reduce the rate of formation of metastases.

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According todays level of knowledge some cytostatics act better under hyperthermia, so that the efficacy of sCMT can be increased by combination with well adapted chemotherapies. Some side effects of cytostatics can be alleviated by the relative hyperoxemia. On the basis of this complex interaction, the application of an individually adapted chemotherapy in combination with the sCMT makes sense for some tumors and is in general well tolerated.

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3. What side effects can occur?
During the first days after the sCMT main treatment, the occurrence of fever up to 39 °C (102.2 °F) axillary (under the arm) can be interpreted as an expression of a strong immunostimulation and is desirable in most cases. At this time, exhaustion, weakness, nausea, vomiting, headaches, diarrhea, and the temporary intensification of existing and/or the occurrence of new pains as well as herpes labialis, oralis et nasalis (blisters on the lips, and on the mucous membrane of the mouth and the nose) can however also occur.

Occasionally thermally conditioned disturbances of the cell tissue metabolism in the different layers of the skin and the subcutis fat tissue, dependent on individual factors (e. g. vascularization), can lead to thermal tissue injuries. Cases requiring treatment are however observed in a few per cent of the therapies. Further temporary functional disturbances of peripheral nerves with strength reductions or malaise predominantly in single big extremities can occur.

In rare single cases after sCMT, an increased amount of oncolytical products can lead to an overstrain of the excretory mechanism (liver, kidney). As a consequence, temporary jaundice (icterus) as well as an increase of the liver and kidney values may occur. Although the side effects of most of the cytostatics are more mild than those of conventional chemotherapy, in very few cases toxic effects of isolated cytostatics caused by the sCMT were observed. Frequently most a transient reduction of number of white blood cells and blood platelets were observed.

Within the sCMT main treatment a deep intravenious anesthesia is applied. The patient is unable to drive a car for at least three days after the sCMT main treatment. In the following days as well, due to various reasons (e.g. after-effects of the chemotherapy or additional medications), the ability to react can be reduced and therefore the driving ability is considerably limited.

 

4. Treatment procedure at our former clinic?
Before the treatment a detailed educational dialog takes place, in which the basis principles, side effects and so on of sCMT will be explained and in which further questions of the patients can be discussed. The frame treatment, which is positioned before and after the sCMT main treatment, serves to improve the conditioning and convalescence of the organism and if necessary also for immunostimulation. Depending on initial situation of the patient (for example, Oxygen Multistep Therapy was realized directly before), one to eight days before and one to two weeks after the sCMT treatment are scheduled. At this time, after a comprehensive medical initial talk with a clinical examination, the determination of all the relevant laboratory and procedural parameters also takes place. If the prior medical-imaging reports from the family doctor (for example sonographics, X-rays, CTs, MRIs, nuclear medical graphics) are too old, these examinations must be brought up-to-date in a radiological clinic in Dresden before the sCMT in order to determine the extent of the tumor structures exactly.

The stationary admission takes place not later than the day before the sCMT main treatment. On the day of sCMT main treatment the patient comes to the hyperthermia area of the clinic with an empty stomach (on the day prior to the treatment, eating is permitted until 8:00 p.m. and drinking until 10:00 p.m.). After your current body weight is measured, there takes place a premedication and the placing of a indwelling bladder catheter. The patient then lies naturally down on the net-bed of the IRATHERM®2000. The ensuing preparation serves to intensively monitor all the body functions. Two peripheral venous accesses in the form of flexible soft-tip catheters on both underarms are the precondition for infusions, intravenous injections and blood sampling. The painless localization of the thermometric probes (rectal, axillary, as well as on the skin of the stomach and the back), of the pulse oxymeter (on the right middle finger) and of the ECG miniature adhesive electrodes completes the intensive medical monitoring. During the whole treatment time, the ECG and oxygen saturation are very closely observed and all the relevant parameters are monitored by means of blood samples (for blood-gas analyses) as well as blood pressure measurements every 15 minutes. In this way possible deviations are recognized and corrected early, whereby serious disturbances can be averted to the greatest possible extent.

During an approximately 60-minute controlled infusion period, still at normal body-temperature, the blood glucose level is increased by three- or four-fold of the initial value (by continuing the infusion during the sCMT main treatment, the blood glucose level attains five to six-fold of the initial value). Then the warming-up procedure (hyperthermia) begins at approximately the same time as the application of a deep intravenous anesthesia (at maintained spontaneous respiration; no intratrachial anesthesia) which acts until the end of the sCMT main treatment. By means of infrared-A (short-wave part of the infrared spectrum) the body-core temperature is raised to approx. 42 °C (107.6 °F) within about 90 minutes. If chemotherapy is scheduled, it is administered as a rule during the warming-up phase at the optimum temperature for the drug.

In the following so-called temperature plateau phase, a mean temperature from
42.0 °C to 42.3 °C (107.6°F to 108.1°F) is constantly maintained over 60 to 90 minutes. The cooling-down phase lasts for approximately another 90 minutes and uses the same monitoring measures as the warming-up and the plateau phase. An ant emetic (a means to reduce vomiting) is added to the infusion during the last period, if required.

During the sCMT main-treatment, lasting altogether approx. 5 to 7 hours, the doctor and nurse are continuously at side of the patient. After the patient is transferred to the adjoining intensive-care unit, an intensive post-care period follows, in which infusion is continued. 24 to 48 hours later the patient can be moved to the normal ward or can be picked up by a accompanying person. Subsequently the ambulatory frame treatment continues for approximately 1 or 2 weeks. During this time, several hemograms (blood-picture tests) are performed and, if needed, medicine to stimulate the production of white-blood corpuscles and blood platelets is administered.

After a comprehensive concluding talk, you can begin your trip home. We recommend two ambulant restagings after 4 to 6 weeks and after a quarter year.

 

5. What the patient should also know and consider
To make sure, if there is an indication for sCMT treatment for the patient or not, copies of all available operation reports, histologies, X-rays, CT’s (computed tomographies), MRI’s (magnetic resonance imaging), sonography (ultrasound) results, epicrises, physicians’ letters (respectively on-going, intermediate or therapy reports) are needed.

After the last treatment, the patient will receive the therapy data in a summarized treatment report, which will be made available to his doctor at home. The summarized treatment report contains the indication argument for applying sCMT.

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