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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334984 |
RATIONALE: Glutamine may help prevent mucositis, or mouth sores, in patients receiving chemotherapy for sarcoma. It is not yet known whether glutamine is more effective than a placebo in preventing mucositis in patients receiving chemotherapy for sarcoma.
PURPOSE: This randomized clinical trial is studying glutamine to see how well it works compared to a placebo in preventing oral mucositis in patients receiving chemotherapy for sarcoma.
Condition | Intervention |
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Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: glutamine Procedure: chemoprotection Procedure: management of therapy complications Procedure: therapeutic nutritional supplementation |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Prevention of Mucositis in Children With AES-14 (IND#36978), a Glutamine Based Oral Care Regimen, for Patients Diagnosed With Solid Tumors: A Randomized Placebo-Controlled Clinical Study |
Estimated Enrollment: | 180 |
Study Start Date: | January 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (5-10 years vs 11-18 years vs 19-30 years) and diagnosis (Ewing's sarcoma vs osteogenic sarcoma vs rhabdomyosarcoma vs other sarcomas). Patients are randomized to 1 of 2 treatment arms.
Caregivers assess the patient's mouth daily while the patient is receiving the study drug. Caregivers keep a daily diary rating the patient's oral mucosal areas and degree of pain, describing the patient's oral intake, and documenting that the study drug was used and standardized oral care was performed.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
Ages Eligible for Study: | 5 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosed with any of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000469005, COG-ANUR0532 |
Study First Received: | June 7, 2006 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00334984 |
Health Authority: | Unspecified |
childhood fibrosarcoma childhood neurofibrosarcoma childhood synovial sarcoma chondrosarcoma localized osteosarcoma metastatic osteosarcoma metastatic childhood soft tissue sarcoma nonmetastatic childhood soft tissue sarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor localized Ewing sarcoma/peripheral primitive neuroectodermal tumor previously treated childhood rhabdomyosarcoma |
previously untreated childhood rhabdomyosarcoma childhood alveolar soft-part sarcoma childhood angiosarcoma childhood epithelioid sarcoma childhood leiomyosarcoma childhood liposarcoma localized childhood malignant fibrous histiocytoma of bone metastatic childhood malignant fibrous histiocytoma of bone childhood malignant mesenchymoma dermatofibrosarcoma protuberans childhood desmoplastic small round cell tumor |
Histiocytoma, Malignant Fibrous Fibrosarcoma Neuroectodermal Tumors, Primitive Leiomyosarcoma Histiocytoma, Benign Fibrous Epithelioid sarcoma Ewing's family of tumors Malignant mesenchymal tumor Alveolar soft part sarcoma Osteogenic sarcoma Soft tissue sarcomas Sarcoma, Synovial Dermatofibrosarcoma protuberans Neoplasms, Connective and Soft Tissue Ewing's sarcoma |
Sarcoma, Ewing's Chondrosarcoma Neuroepithelioma Sarcoma, Alveolar Soft Part Desmoplastic small round cell tumor Rhabdomyosarcoma Mucositis Synovial sarcoma Osteosarcoma Hemangiosarcoma Dermatofibrosarcoma Neuroectodermal Tumors Liposarcoma Histiocytoma Peripheral neuroectodermal tumor |
Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue |