Clinical trial NCT00334984: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Donna L. Betcher, RN, MSN
role: STUDY_CHAIR
References: