Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

NCT ID: NCT00334984

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

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.

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

glutamine

Intervention Type: DRUG

chemoprotection

Intervention Type: PROCEDURE

management of therapy complications

Intervention Type: PROCEDURE

therapeutic nutritional supplementation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Donna L. Betcher, RN, MSN

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

COG-ANUR0532

Identifier Type: -

Identifier Source: secondary_id

CDR0000469005

Identifier Type: -

Identifier Source: secondary_id

ANUR0532

Identifier Type: -

Identifier Source: org_study_id