NCT00334984WithdrawnNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Children's Oncology Group
Study Overview
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.
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 of chemotherapy in patients with sarcomas.
Secondary
- Compare the rates of mucositis-related chemotherapy dose reductions for the subsequent course of anthracycline-based chemotherapy in patients treated with AES-14 vs placebo.
- Compare the rates of mucositis-related delays of chemotherapy administration for the next chemotherapy course in patients treated with AES-14 vs placebo.
- Compare the rates of systemic and oral infections during the first course of chemotherapy in patients treated with AES-14 vs placebo.
- Compare the number of days of narcotic use for mucositis-related pain during the first course of chemotherapy in patients treated with AES-14 vs placebo.
- Determine the inter-rater reliability between caregivers and nurses in the use of the modified Walsh scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Supportive Care
- Masking
- Double
Eligibility Criteria
- Ages
- 5 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Investigators
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