Contact information
Type
Scientific
Primary contact
Dr Georg Seifert
ORCID ID
Contact details
Charité - University Medicine Berlin
Mittelallee 6a
Augustenburger Platz 1
Berlin
13353
Germany
+49 (0)30 450 666087
georg.seifert@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09-2004 PaedonkoChar
Study information
Scientific title
Acronym
Study hypothesis
Anthroposophic supportive medicine can reduce the incidence and the cause of treatment-related toxicity in children receiving cancer therapy.
As of 01/06/2009 this record was updated to include an extension to the anticipated end date of this trial; the initial end date was 31/03/2009.
Ethics approval
The trial was accepted by the Local Ethics Committee of Charite University Medicine, Berlin on18/08/2005
Study design
Randomised, controlled, phase IV trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Solid tumours, lymphoma and leukaemia
Intervention
We plan to include 340 children with malignancies to be randomly allocated to an arm with anthroposophically-supported medicine in addition to standard treatment compared to an arm with standard treatment alone.
The anthroposophical therapy, which includes mistletoe, will be partly given preventively in parallel to chemotherapy, and partly as an exactly defined intervention stand-by medication.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Quality of life questionnaires
Overall trial start date
01/11/2005
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The trial will be open to patients being treated according to current protocols for solid tumours, lymphoma and leukaemia in the German Society for Paediatric Oncology and Haematology (GPOH), aged between 1 and 18 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
340
Participant exclusion criteria
Current use of any experimental therapy
Recruitment start date
01/11/2005
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Charité - University Medicine Berlin
Berlin
13353
Germany
Sponsor information
Organisation
Helixor Heilmittel GmbH and Co. (Germany)
Sponsor details
Helixor Heilmittel GmbH and Co. KG
Fischermühle 1
Rosenfeld
72348
Germany
+49 (0)74 289 350
jschierholz@helixor.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Helixor Heilmittel GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Weleda AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
WALA Heilmittel GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list