Status:
WITHDRAWN
Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Eligibility:
All Genders
5-30 years
Phase:
NA
Brief Summary
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 mu...
Detailed Description
OBJECTIVES: Primary * Compare the efficacy of a new preparation of glutamine (AES-14) vs placebo in reducing the incidence of grade 3 or 4 chemotherapy-induced oral mucositis during the first course...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosed with any of the following:
- Ewing's sarcoma
- Osteogenic sarcoma
- Rhabdomyosarcoma
- Other sarcomas (i.e., fibrosarcoma or synovial sarcoma)
- Scheduled to receive first course of chemotherapy that includes ≥ 75 mg/m² of anthracyclines
- Total modified Walsh score ≤ 2 (mucositis score)
- PATIENT CHARACTERISTICS:
- Must have a caregiver (parent, other relative, or friend) available to perform daily mucositis assessments
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- No history of hypersensitivity to any known component of AES-14
- PRIOR CONCURRENT THERAPY:
- No prior glutamine (AES-14)
- No prior or concurrent head and/or neck radiation therapy
- No concurrent supplementation with another glutamine product
- No other concurrent agents for mucositis prophylaxis
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00334984
Start Date
January 1 2007
Last Update
July 11 2013
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