Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

NCT00334984 | Withdrawn

• 3 other identifiers: ANUR0532COG-ANUR0532CDR0000469005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma

Keywords

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

Interventions

glutamine DRUG

chemoprotection PROCEDURE

management of therapy complications PROCEDURE

therapeutic nutritional supplementation PROCEDURE

Eligibility Criteria

• Age: 5 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Sarcoma; Fibrosarcoma; Chondrosarcoma; Osteosarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Hemangiosarcoma; Liposarcoma; Malignant mesenchymal tumor; Dermatofibrosarcoma; Desmoplastic Small Round Cell Tumor

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Bone Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Donna L. Betcher, RN, MSN

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: January 1, 2007
• Last Updated: July 11, 2013

Record last verified: 2013-07