Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

This study has been withdrawn prior to enrollment.
(Withdrawn due to inability to reach an acceptable agreement with industry sponsor)
Sponsor:
Collaborator:
Information provided by:
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00334984
First received: June 7, 2006
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Drug: glutamine
Procedure: chemoprotection
Procedure: management of therapy complications
Procedure: therapeutic nutritional supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Enrollment: 0
Study Start Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   5 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334984

Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Donna L. Betcher, RN, MSN Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334984     History of Changes
Other Study ID Numbers: ANUR0532, COG-ANUR0532, CDR0000469005
Study First Received: June 7, 2006
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
localized childhood malignant fibrous histiocytoma of bone
metastatic childhood malignant fibrous histiocytoma of bone
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
childhood malignant mesenchymoma
dermatofibrosarcoma protuberans
childhood desmoplastic small round cell tumor

Additional relevant MeSH terms:
Histiocytoma
Fibrosis
Histiocytoma, Benign Fibrous
Mucositis
Histiocytoma, Malignant Fibrous
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014