Evaluation of anthroposophic supportive medicine on treatment-related toxicity in children receiving cancer therapy - anthroposophic supportive medicine

• Conditions: The trial will be open to patients being treated according to current protocols for solid tumors and leukemias/lymphomas of the German Society for Paediatric Oncology and Haematology (GPOH); MedDRA version: 12.1Level: LLTClassification code 10025691Term: Malignant neoplasm NOS

• Registration Number: EUCTR2004-002711-83-DE
• Lead Sponsor: HELIXOR Heilmittel GmbH & Co.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-03
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

We plan to include children with paediatric malignancies. The trial will be open to patients being treated according to current protocols for solid tumors and leukemias/lymphomas of the German Society for Paediatric Oncology and Haematology (GPOH).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any severe pre-existing disease except the oncological disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim is to investigate the efficiency and safety of anthroposophic supportive medicine including mistletoe plant extracts on any side effects in children with malignancies during the conventional chemotherapy protocols.<br><br>;Secondary Objective: The aim is to investigate the influence of anthroposophic supportive medicine including mistletoe plant extracts on therapytoxicity and quality of life in children with malignancies treated with conventional chemotherapy protocols.;Primary end point(s): Score (NCI-CTC scales) of side effects during the intensive phase of the chemotherapy.