Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
NCT ID: NCT00080873
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
195 participants
INTERVENTIONAL
2004-04-30
2011-01-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.
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Detailed Description
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* 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 undergoing hematopoietic stem cell transplantation.
* Determine the safety of this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1 before transplantation.
* Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation.
In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score ≤ 1 for 2 consecutive days.
Patients are followed until day 100 post-transplantation.
PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Receive Traumeel S
Traumeel S
Receive placebo
Placebo
Interventions
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Traumeel S
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
25 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Susan F. Sencer, MD
Role: STUDY_CHAIR
Children's Hospitals and Clinics of Minnesota - Minneapolis
Indira Sahdev, MD
Role: STUDY_CHAIR
Schneider Children's Hospital
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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References
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Sencer SF, Zhou T, Freedman LS, Ives JA, Chen Z, Wall D, Nieder ML, Grupp SA, Yu LC, Sahdev I, Jonas WB, Wallace JD, Oberbaum M. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children's Oncology Group. Bone Marrow Transplant. 2012 Nov;47(11):1409-14. doi: 10.1038/bmt.2012.30. Epub 2012 Apr 16.
Other Identifiers
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CDR0000356179
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ACCL0331
Identifier Type: OTHER
Identifier Source: secondary_id
ACCL0331
Identifier Type: -
Identifier Source: org_study_id
NCT00228800
Identifier Type: -
Identifier Source: nct_alias
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