title: A pilot study of Auron Misheil Therapy in patients with advanced cervical cancer: tumor response and its correlation with clinical benefit response, and preliminary quality of life data.
abstract: This pilot study of Auron Misheil Therapy (AMT) in women with advanced cervical cancer was an open-label, single arm study to collect initial safety, efficacy, and quality of life data. Fifteen women with stage IIIb or IVa cervical cancer were given twice daily intramuscular injections of AMT (insulin, chlorpheniramine and camomile extract) for 3 months. Objective tumor response was evaluated using CT scans and analyzing the data according to the WHO RECIST criteria. Clinical Benefit Response (CBR) was assessed using a composite score comprising Karnovsky performance status, pain intensity and body weight. Safety and tolerability parameters were monitored. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC C-30). Eight out of 15 patients were rated as clinical responders (CBR) at 12 weeks. One patient had a partial response and 11 stable disease (WHO RECIST criteria). AMT was well tolerated. An initial analysis showed improvement in quality of life (EORTC C-30). Promising response rates, early indications of improved quality of life, and no significant safety issues mean that the second, randomized phase of the trial can be initiated with a longer treatment duration. Patients with advanced cervical cancer showed positive clinical responses to Auron Misheil Therapy. The treatment was well tolerated, with indications of improved quality of life.
authors.affiliation: Auron Healthcare GmbH, D-79100 Freiburg, Germany. j.scheele@auronhealthcare.com
authors.forename: Jürgen
authors.initials: J
authors.lastname: Scheele
authors.forename: Faiz
authors.initials: F
authors.lastname: Niazi
authors.forename: Joachim
authors.initials: J
authors.lastname: Drevs
authors.forename: Klaus
authors.initials: K
authors.lastname: Diergarten
authors.forename: Papa
authors.initials: P
authors.lastname: Toure
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002118:Calcium / Q000627:therapeutic use*; D002744:Chlorpheniramine / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007328:Insulin / Q000627:therapeutic use*; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; C542427:Auron-Misheil-Therapy; D007328:Insulin; D010936:Plant Extracts; D002744:Chlorpheniramine; D002118:Calcium