Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)

Criteria

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