Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up
Georg Seifert,
Sarah B. Blakeslee,
Gabriele Calaminus,
Farid I. Kandil,
Andrea Barth,
Toralf Bernig,
Carl Friedrich Classen,
Selim Corbacioglu,
Jürgen Föll,
Sven Gottschling,
Bernd Gruhn,
Claudia vom Hoff-Heise,
Holger N. Lode,
David Martin,
Michaela Nathrath,
Felix Neunhoeffer,
Arnulf Pekrun,
Beate Wulff,
Tycho Zuzak,
Günter Henze,
Alfred Längler
Affiliations
Georg Seifert
Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin
Sarah B. Blakeslee
Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin
Gabriele Calaminus
Department of Pediatric Hematology and Oncology, University Children’s Hospital
Farid I. Kandil
Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin
Andrea Barth
Institute of Applied Analysis and Numerical Simulation, Research Group for Computational Methods for Uncertainty Quantification, University of Stuttgart
Toralf Bernig
Department of Pediatrics, Martin Luther University Halle-Wittenberg
Carl Friedrich Classen
Division of Pediatric Oncology, Hematology and Palliative Medicine Section, Department of Pediatrics and Adolescent Medicine, University Medicine Rostock
Selim Corbacioglu
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital Regensburg
Jürgen Föll
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital Regensburg
Sven Gottschling
Center for Palliative Care and Pediatric Pain Medicine, Saarland University Medical Center
Bernd Gruhn
Department of Pediatrics, Jena University Hospital
Claudia vom Hoff-Heise
Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin
Holger N. Lode
Department of Pediatric Hematology and Oncology, University Medicine
David Martin
Department of Hematology Oncology, University Children’s Hospital
Michaela Nathrath
Pediatric Hematology and Oncology, Klinikum Kassel
Felix Neunhoeffer
Department of Pediatric Cardiology, Pulmonology and Pediatric Intensive Care Medicine, University Children’s Hospital
Arnulf Pekrun
Department of Pediatric Hematology and Oncology, Hospital Bremen-Mitte
Beate Wulff
Department of Pediatric Hematology-Oncology, Pediatrics III, University Hospital of Essen
Tycho Zuzak
Department of Pediatric Hematology-Oncology, Pediatrics III, University Hospital of Essen
Günter Henze
Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin Berlin
Alfred Längler
Department of Integrative Pediatric and Adolescent Medicine, Gemeinschaftskrankenhaus Herdecke
Abstract Background Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1–18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients. Methods Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales. Results Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up. Discussion In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.
