WithdrawnNot Applicable

Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

Stopped: Withdrawn due to inability to reach an acceptable agreement with industry sponsor

0Started 2007-01

Plain-language 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 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.

Who can participate

Age range5 Years – 30 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Trial details

NCT IDNCT00334984

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Childhood Malignant Fibrous Histiocytoma of Bone trials