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| Sponsors and Collaborators: |
Children's Oncology Group 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 |
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Kidney Cancer Leukemia Lymphoma Neuroblastoma Oral Complications of Cancer and Cancer Therapy Sarcoma |
Drug: Traumeel S |
| MedlinePlus related topics: | Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Neuroblastoma Soft Tissue Sarcoma |
| ChemIDplus related topics: | Traumeel S |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| 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 |
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 |
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Susan F. Sencer, MD | Children's Hospitals and Clinics of Minnesota - Minneapolis |
| Investigator: | Indira Sahdev, MD | Schneider Children's Hospital |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Featured trial article
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| Study ID Numbers: | CDR0000356179, COG-ACCL0331 |
| First Received: | April 7, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00080873 |
| Health Authority: | United States: Federal Government |
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