[Supplementary treatment with Esberitox of female patients undergoing curative adjuvant irradiation following breast cancer].
1. The study was supposed to investigate a possible prevention or reduction of the toxicity of radiotherapy by an additional treatment with Esberitox. This question arose when performing an investigation about the effect of Esberitox in a combined chemo-radiotherapy. Whereas the latter induces above all a systemic damage to the hemopoietic system, radiotherapy is a regional noxa. 2. The present prospective, randomized study was conducted with 50 patients submitted to curative adjuvant irradiation following surgery for mammary carcinoma. The radiotherapy was performed in the same way in all patients with irradiations of the thoracic wall and the regional lymph nodes. Two groups were built by randomization. The study group received an additional treatment with Esberitox, the control group did not receive an additional treatment. 3. As a result, no protective influence of Esberitox could be demonstrated. The parameters investigated were the peripheral blood count (leucocytes, granulocytes, lymphocytes, monocytes, thrombocytes, hemoglobin, hematocrit) and the incidence of infections. 4. This result diverging from literature is discussed. It is probably affected by volume and extension of the injury induced by a hematotoxic noxa and furthermore by the ability of regeneration. If this ability is exhausted, the protective effect of Esberitox can act no longer. Therefore the essential factor seems to be the duration of exposure to the noxa. Esberitox was effective in case of a short toxicity, it was ineffective in case of prolonged toxicity, if the treatment continuity (noxa) was not broken up by some regeneration intervals. The radiotherapy studied in this trial had a duration of 50 days, and its effect was that of a longterm injury.
D000328:Adult; D000368:Aged; D001772:Blood Cell Count; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D017053:Infection Control; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011832:Radiation Injuries / Q000517:prevention & control*; D011878:Radiotherapy / Q000009:adverse effects*; D011897:Random Allocation
D010936:Plant Extracts; C026057:Esberitox
Zusatzbehandlung mit Esberitox bei Patientinnen mit kurativer adjuvanter Bestrahlung nach Mammakarzinom.