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WithdrawnNCT00334984Updated Jul 11, 2013

Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

An interventional study of glutamine and chemoprotection in Childhood Malignant Fibrous Histiocytoma of Bone and Sarcoma, sponsored by Children's Oncology Group. Withdrawn. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2013-07-11.

Sponsored by Children's Oncology Group · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Withdrawn due to inability to reach an acceptable agreement with industry sponsor
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
5 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

Browse Sarcoma studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 30 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Masking
Double
Enrollment
0 participants (actual)

Interventions

  • Drugglutamine
  • Procedurechemoprotection
  • Proceduremanagement of therapy complications
  • Proceduretherapeutic nutritional supplementation
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00334984
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
Jun 8, 2006
Start date
Jan 2007
Last update
Jul 11, 2013

Study contacts

Donna L. Betcher, RN, MSN
study chair · Mayo Clinic
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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