Treatment of chemotherapie-induced oral mucositis MedDRA version: 8.1 Level: LLT Classification code 10028130 Term: Mucositis oral
Conditions
Interventions
Trade Name: Traumeel S
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Oromucosal solution
Route of administration of the placebo: Oromucosal use
Sponsors
University Hospital of Muenster
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Tolerability of the treatment - Occurance of Adverse Events - Necessity of parenteral nutrition - Total amount of analgetics used because of painful mucositis - Duration of mucositis (Total number of days) ;Primary end point(s): Treatment ends when Patients meet the “completion of therapy” criteria: - Walsh-score is one or less for two consecutive days - Minimum period of treatment are14 days, maximum period of treatment are 28 days | — |
Countries
Germany
Outcome results
None listed