The trial will be open to patients being treated according to current protocols for solid tumors and leukemias/lymphomas of the German Society for Paediatric Oncology and Haematology (GPOH) MedDRA version: 12.1 Level: LLT Classification code 10025691 Term: Malignant neoplasm NOS
Conditions
Interventions
Trade Name: HELIXOR® A 50 mg
Product Name: HELIXOR® A 50 mg
Pharmaceutical Form: Injection*
Trade Name: HELIXOR® A 20 mg
Product Name: HELIXOR® A 20 mg
Pharmaceutical Form: Injection*
Trade Name: HE
Sponsors
HELIXOR Heilmittel GmbH & Co.KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We plan to include children with paediatric malignancies. The trial will be open to patients being treated according to current protocols for solid tumors and leukemias/lymphomas of the German Society for Paediatric Oncology and Haematology (GPOH). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any severe pre-existing disease except the oncological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to investigate the efficiency and safety of anthroposophic supportive medicine including mistletoe plant extracts on any side effects in children with malignancies during the conventional chemotherapy protocols. ;Secondary Objective: The aim is to investigate the influence of anthroposophic supportive medicine including mistletoe plant extracts on therapytoxicity and quality of life in children with malignancies treated with conventional chemotherapy protocols.;Primary end point(s): Score (NCI-CTC scales) of side effects during the intensive phase of the chemotherapy. | — |
Countries
Germany
Outcome results
None listed