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
Scientific
Charité - University Medicine Berlin
Mittelallee 6a
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)30 450 666087 |
|---|---|
| georg.seifert@charite.de |
Study information
| Study design | Randomised, controlled, phase IV trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Quality of life questionnaires |
| Overall study start date | 01/11/2005 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - University Medicine Berlin
Berlin
13353
Germany
13353
Germany
Sponsor information
Helixor Heilmittel GmbH and Co. (Germany)
Industry
Industry
Helixor Heilmittel GmbH and Co. KG
Fischermühle 1
Rosenfeld
72348
Germany
| Phone | +49 (0)74 289 350 |
|---|---|
| jschierholz@helixor.de | |
| Website | http://www.helixor.de |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
