Table 1.
Inclusion & exclusion criteria anthroposophic supportive therapy study
Inclusion Criteria: • Age between 1 year and 18 years • Morphologically and/or immunologically • confirmed diagnosis of a following disease: ○ Hodgkin's disease (EuroNET-PHL-C1) ○ Acute lymphoblastic leukemia (ALL); ○ (ALL- BFM 2000; ALL-BFM 2000 incl. EsPhALL) ○ ALL (COALL 07-03) ○ Relapse of ALL (ALL-Rez BFM 2002) ○ Acute myeloid leukemia (AML) (AML-BFM 2004) ○ Nephroblastoma (SIOP 2001 / GPOH) ○ Germ cell tumors MAKEI 96 ○ Mature B-NHL / B-ALL (B-NHL - BFM 04; B- NHL BFM Rituximab) ○ Lymphoblastic lymphoma (until 06/2008 Euro-LB-02; from 07/2008 NHL-BFM 90) ○ Medulloblastoma / PNET or Ependymoma (HIT 2000) ○ Brain tumors-highly malignant (gliomas HIT-GBM-D; until 05/2009) ○ Neuroblastoma (NB 2004 and NB 2004 HR) ○ Osteosarcoma (EURAMOS 1) ○ Ewing's sarcoma (until 09/2009 EURO- E.W.I.N.G '99; from 10/2009 EWING 2008) ○ Rhabdomyosarcoma (CWS 2002P; until 6/2009) • Protocol-compliant therapy for the included diseases • Treatment in one of the study centers • Patients must be available during the treatment period and be able to comply with the study plan • Written consent for participation from the patient or the legal guardian |
Exclusion Criteria: • Serious pre-existing/ co-existing psychiatric illness • Other existing serious medical condition that could interfere with the patient’s ability to receive trial- appropriate therapy • Any other condition or therapy that, in the opinion of the treating physician, could pose a risk to the patient or interfere with the objectives of the study • Absence of or incomplete informed consent form • Known allergies to any component of the study medications • Pregnancy or not using effective contraception (hormonal contraception, barrier) • Other experimental treatment during or within this study (including chemotherapeutic drugs or immunotherapies not listed in the protocol) |