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

ISRCTN ISRCTN64676790
DOI https://doi.org/10.1186/ISRCTN64676790
Secondary identifying numbers 09-2004 PaedonkoChar
Submission date
31/01/2006
Registration date
30/06/2006
Last edited
01/06/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

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

Study information

Study designRandomised, controlled, phase IV trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesAnthroposophic 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) studiedSolid tumours, lymphoma and leukaemia
InterventionWe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresQuality of life questionnaires
Overall study start date01/11/2005
Completion date31/03/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit18 Years
SexBoth
Target number of participants340
Key inclusion criteriaThe 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 criteriaCurrent use of any experimental therapy
Date of first enrolment01/11/2005
Date of final enrolment31/03/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - University Medicine Berlin
Berlin
13353
Germany

Sponsor information

Helixor Heilmittel GmbH and Co. (Germany)
Industry

Helixor Heilmittel GmbH and Co. KG
Fischermühle 1
Rosenfeld
72348
Germany

Phone +49 (0)74 289 350
Email jschierholz@helixor.de
Website http://www.helixor.de
ROR logo "ROR" https://ror.org/02thwp314

Funders

Funder type

Industry

Helixor Heilmittel GmbH (Germany)

No information available

Weleda AG (Germany)

No information available

WALA Heilmittel GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan