A randomized. double-blind, placebo-controlled, phase III trial for the efficacy of Traumeel S in the prevention and treatment of chemotherapie-induced Mucositis in Patients undergoing allogeneic stem cell transplantation - Traumeel

Conditions: Treatment of chemotherapie-induced oral mucositis
MedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oral

Registration Number: EUCTR2006-000821-74-DE

Lead Sponsor: niversity Hospital of Muenster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

-Patients = 2 years, undergoing allogeneic stem cell transplantation, receiving any type of myeloablative high-dosis-chemotherapie with/without TBI = 8 Gy
-Adults: written inform consent of full age subjects
-Children: written inform consent of the parents/guardian and as possible of the children themselves after information
-Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-No written informed consent
-Pregnant or nursing patients
-Prior inclusion in this study
-Patients with known allergy to an ingredient of Traumeel® S
-Patients with other condition or illness, which in estimation of the investigator couldn’t be treated as written in protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The proof of the effictiveness of Traumeel S in the course of time in comparison with placebo by the judgement of the mucositis (using the modified Walsh-Score).;Secondary Objective: -Degree of the mucositis, incidence of grad 0 and I or II and higher, according to WHO<br>- Tolerability of the treatment<br>-Occurance of Adverse Events<br>-Necessity of parenteral nutrition <br>-Total amount of analgetics used because of painful mucositis<br>-Duration of mucositis (Total number of days)<br><br>;Primary end point(s): Treatment ends when Patients meet the completion of therapy” criteria:<br>-Walsh-score is one or less for two consecutive days <br>-Minimum period of treatment are14 days, maximum period of treatment are 28 days<br>

Secondary Outcome Measures