Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00334984

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

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Glutamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	180
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

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

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Donna L. Betcher, RN, MSN

Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000469005, COG-ANUR0532
Study First Received:	June 7, 2006
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00334984
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Histiocytoma, Malignant Fibrous
Fibrosarcoma
Neuroectodermal Tumors, Primitive
Leiomyosarcoma
Histiocytoma, Benign Fibrous
Epithelioid sarcoma
Ewing's family of tumors
Malignant mesenchymal tumor
Alveolar soft part sarcoma
Osteogenic sarcoma
Soft tissue sarcomas
Sarcoma, Synovial
Dermatofibrosarcoma protuberans
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma

Sarcoma, Ewing's
Chondrosarcoma
Neuroepithelioma
Sarcoma, Alveolar Soft Part
Desmoplastic small round cell tumor
Rhabdomyosarcoma
Mucositis
Synovial sarcoma
Osteosarcoma
Hemangiosarcoma
Dermatofibrosarcoma
Neuroectodermal Tumors
Liposarcoma
Histiocytoma
Peripheral neuroectodermal tumor

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on January 16, 2009