Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up

• Published in: BMC cancer Vol. 22; no. 1; p. 652
• Main Authors: Seifert, Georg, Blakeslee, Sarah B, Calaminus, Gabriele, Kandil, Farid I, Barth, Andrea, Bernig, Toralf, Classen, Carl Friedrich, Corbacioglu, Selim, Föll, Jürgen, Gottschling, Sven, Gruhn, Bernd, Vom Hoff-Heise, Claudia, Lode, Holger N, Martin, David, Nathrath, Michaela, Neunhoeffer, Felix, Pekrun, Arnulf, Wulff, Beate, Zuzak, Tycho, Henze, Günter, Längler, Alfred
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 13.06.2022; BioMed Central; BMC
• Subjects: Anthroposophic medicine; Anthroposophical medicine; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Cancer; Cancer in children; Cancer therapies; Care and treatment; Chemotherapy; Child; Clinical trials; Complementary cancer treatment; Diagnosis; Follow-Up Studies; Humans; Hypotheses; Integrative Medicine; Intervention; Malignancy; Medical Oncology; Methods; Mistletoe; Neoplasms - drug therapy; Neoplasms - etiology; Oncology; Patients; Pediatric oncology trial; Pediatrics; Quality of life; Randomized controlled trial; RCT; Risk factors; Services; Statistical analysis; Survival; Toxicity; Tumors; Germany; RCT; Complementary cancer treatment; Mistletoe; Randomized controlled trial; Anthroposophic medicine; Pediatric oncology trial
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-022-09703-0

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. 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. 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. 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.