Condition category
Cancer
Date applied
31/01/2006
Date assigned
30/06/2006
Last edited
01/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.helixor.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes