| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000356179 | Other Identifier | Clinical Trials.gov | |
| COG-ACCL0331 | Other Identifier | Children's Oncology Group |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive Traumeel S | Experimental |
| |
| Receive placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumeel S | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of the modified Walsh mucositis scale | The primary aim of drug efficacy will be measured by the area under the curve (AUC) of the modified Walsh mucositis scale. Scores will be assigned for each region of oral mucosa and totaled for daily score. AUC will be obtained by graphing the total scores recorded every day during follow-up, linking time adjacent points by a straight line and calculating the area under the resulting polygon. The measurement of AUC incorporates both severity and duration of symptoms. | Length of study |
| Measure | Description | Time Frame |
|---|---|---|
| Two sample t test and the Wilcoxon sum test. | Total amount of narcotics used, days of total TPN and NG feedings in patients who receive Traumeel® S and placebo will be compared. The statistical tests to be applied are the two sample t test and the Wilcoxon sum test. | Length of study |
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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:
Availability of 1 of the following donor types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Susan F. Sencer, MD | Children's Hospitals and Clinics of Minnesota - Minneapolis | Study Chair |
| Indira Sahdev, MD | Schneider Children's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22504933 | Result | 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. |
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|
| Jonsson Comprehensive Cancer Center at UCLA |
| Los Angeles |
| California |
| 90095-1781 |
| United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Stanford Comprehensive Cancer Center at Stanford University Medical Center | Stanford | California | 94305 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 95813 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1083 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Children's Hospital of New Orleans | New Orleans | Louisiana | 70118 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| C.S. Mott Children's Hospital at University of Michigan | Ann Arbor | Michigan | 48109-0238 | United States |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan | 49503-2560 | United States |
| Children's Hospitals and Clinics of Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Schneider Children's Hospital | New Hyde Park | New York | 11040 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104-9958 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Prince of Wales Private Hospital | Randwick | New South Wales | 2031 | Australia |
| Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 3N6 | Canada |
| Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec | H3H 1P3 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D009396 | Wilms Tumor |
| D012008 | Recurrence |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D002051 | Burkitt Lymphoma |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C433370 | Traumeel S |
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