Seifert, Georg and Blakeslee, Sarah B. and Calaminus, Gabriele and Kandil, Farid and Barth, Andrea and Bernig, Toralf and Classen, Carl Friedrich and Corbacioglu, Selim and Foell, Juergen and Gottschling, Sven and Gruhn, Bernd and Vom Hoff-Heise, Claudia and Lode, Holger N. and Martin, David and Nathrath, Michaela and Neunhoeffer, Felix and Pekrun, Arnulf and Wulff, Beate and Zuzak, Tycho and Henze, Guenter and Laengler, Alfred (2022) Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up. BMC CANCER, 22 (1): 652. ISSN , 1471-2407
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NON-HODGKIN-LYMPHOMA; ALBUM-L. EXTRACT; CANCER-PATIENTS; MISTLETOE; CHILDREN; THERAPY; COMPLEMENTARY; SAFETY; Pediatric oncology trial; Anthroposophic medicine; Mistletoe; Complementary cancer treatment; RCT; Randomized controlled trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Abteilung für Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2023 07:43 |
| Last Modified: | 14 Dec 2023 07:43 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58664 |
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