Clinical trial · Interventional

Glutamine in Preventing Oral Mucositis in Patients Receiving Chemotherapy for Sarcoma

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

NCT00334984CI-TRIAL-00011321withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Withdrawn due to inability to reach an acceptable agreement with industry sponsor

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Childhood Malignant Fibrous Histiocytoma of Bone	Childhood Undifferentiated High Grade Pleomorphic Sarcoma of Bone	ALIAS	0.90
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
chemoprotection	Procedure	—	UNRESOLVED
glutamine	Drug	—	UNRESOLVED
management of therapy complications	Procedure	—	UNRESOLVED
therapeutic nutritional supplementation	Procedure	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 5 Years
Maximum age: 30 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jan 1, 2007
Primary completion: —
Completion: —
First posted: Jun 8, 2006
Last update posted: Jul 11, 2013
Enrollment: 0 (actual)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
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

Data updated 22 days agoSource updated Jul 11, 2013source: clinicaltrials

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