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Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

Primary Purpose

Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glutamine
chemoprotection
management of therapy complications
therapeutic nutritional supplementation
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Malignant Fibrous Histiocytoma of Bone focused on measuring 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

Eligibility Criteria

5 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2006
    Last Updated
    July 9, 2013
    Sponsor
    Children's Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00334984
    Brief Title
    Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn due to inability to reach an acceptable agreement with industry sponsor
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (5-10 years vs 11-18 years vs 19-30 years) and diagnosis (Ewing's sarcoma vs osteogenic sarcoma vs rhabdomyosarcoma vs other sarcomas). Patients are randomized to 1 of 2 treatment arms. Arm I (glutamine [AES-14]): Patients rinse with oral AES-14 for at least 30 seconds and then swallow (swish and swallow) three times daily beginning on the day of or within 1 day before starting their first course of chemotherapy. Patients also undergo a standard oral care regimen comprising brushing their teeth at least twice daily, 30 minutes or more after taking AES-14, and rinsing with water at least twice daily. Treatment continues until blood counts recover and patient's total modified Walsh score ≤ 2 (mucositis score). Arm II (placebo): Patients swish and swallow oral placebo and undergo a standard oral care regimen as in arm I. Caregivers assess the patient's mouth daily while the patient is receiving the study drug. Caregivers keep a daily diary rating the patient's oral mucosal areas and degree of pain, describing the patient's oral intake, and documenting that the study drug was used and standardized oral care was performed. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    glutamine
    Intervention Type
    Procedure
    Intervention Name(s)
    chemoprotection
    Intervention Type
    Procedure
    Intervention Name(s)
    management of therapy complications
    Intervention Type
    Procedure
    Intervention Name(s)
    therapeutic nutritional supplementation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donna L. Betcher, RN, MSN
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

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