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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00080873 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney Cancer Leukemia Lymphoma Neuroblastoma Oral Complications Sarcoma |
Dietary Supplement: Traumeel S |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel® S (IND#66649) for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation |
| Estimated Enrollment: | 180 |
| Study Start Date: | April 2004 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 3 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation
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
Contacts and Locations
Show 44 Study Locations| Study Chair: | Susan F. Sencer, MD | Children's Hospitals and Clinics of Minnesota - Minneapolis |
| Investigator: | Indira Sahdev, MD | Schneider Children's Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00080873 History of Changes |
| Obsolete Identifiers: | NCT00228800 |
| Other Study ID Numbers: | CDR0000356179, COG-ACCL0331 |
| Study First Received: | April 7, 2004 |
| Last Updated: | November 20, 2010 |
| Health Authority: | United States: Federal Government |
|
oral complications disseminated neuroblastoma previously treated childhood rhabdomyosarcoma recurrent Wilms tumor and other childhood kidney tumors recurrent/refractory childhood Hodgkin lymphoma recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma |
recurrent childhood rhabdomyosarcoma recurrent childhood small noncleaved cell lymphoma untreated childhood acute lymphoblastic leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia juvenile myelomonocytic leukemia recurrent neuroblastoma |
|
Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Neuroblastoma Mucositis Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
