Influence of anthroposophical supportive medicine on treatment-related toxicity in children receiving cancer therapy

ISRCTN	ISRCTN64676790
DOI	https://doi.org/10.1186/ISRCTN64676790
Protocol serial number	09-2004 PaedonkoChar
Sponsor	Helixor Heilmittel GmbH and Co. (Germany)
Funders	Helixor Heilmittel GmbH (Germany), Weleda AG (Germany), WALA Heilmittel GmbH (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Georg Seifert
Scientific

Charité - University Medicine Berlin
Mittelallee 6a
Augustenburger Platz 1
Berlin
13353
Germany

Phone	+49 (0)30 450 666087
Email	georg.seifert@charite.de

Primary study design	Interventional
Study design	Randomised, controlled, phase IV trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	The trial was accepted by the Local Ethics Committee of Charite University Medicine, Berlin on18/08/2005
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Quality of life questionnaires
Completion date	31/03/2012

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	18 Years
Sex	All
Target sample size at registration	340
Key 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
Key exclusion criteria	Current use of any experimental therapy
Date of first enrolment	01/11/2005
Date of final enrolment	31/03/2012

Charité - University Medicine Berlin

Berlin
13353
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan