Status:
COMPLETED
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Leukemia
Eligibility:
All Genders
3-25 years
Phase:
NA
Brief Summary
RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation...
Detailed Description
OBJECTIVES: * Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of chemotherapy-induced (with or without total body irradiation) mucositis in pediatric patients und...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation
- Conditioning chemotherapy regimen for transplantation must be myeloablative
- Source of stem cells from any of the following:
- Bone marrow
- Placental cord
- Cytokine-mobilized peripheral blood
- Availability of 1 of the following donor types:
- HLA-matched sibling or parent
- Related donor mismatched for a single HLA locus (class I or II)
- Unrelated marrow or peripheral blood stem cell donor
- Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor
- PATIENT CHARACTERISTICS:
- Age
- 3 to 25
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- No known allergy to Echinacea
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No concurrent oral vancomycin paste
- No concurrent oral glutamine supplementation
- No other mouth care or oral medications within 30 minutes after administration of study drugs
- No other concurrent treatment to prevent mouth sores
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00080873
Start Date
April 1 2004
End Date
January 1 2011
Last Update
January 7 2016
Active Locations (44)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305