Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer

Study Overview
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Brief Summary
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RATIONALE: Polyvinylpyrrolidone-sodium hyaluronate gel may lessen the pain of oral mucositis, or mouth sores, in patients undergoing treatment for cancer. PURPOSE: This clinical trial is studying how well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer.

Detailed Description
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OBJECTIVES: Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy. OUTLINE: This is a prospective, uncontrolled, open-label, pilot, multicenter study. Beginning before hospital discharge or day 3 after chemotherapy, patients use oral polyvinylpyrrolidone-sodium hyaluronate gel mouth rinse for at least 1 minute, 3 times per day or as needed. Treatment continues for 48 hours. Patients with persistent oral pain may continue treatment with polyvinylpyrrolidone-sodium hyaluronate gel beyond 48 hours. Oral pain and acceptability (i.e., taste) of polyvinylpyrrolidone-sodium hyaluronate gel are assessed periodically using self-reported rating scales. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
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Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)

Conditions
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Brain and Central Nervous System Tumors, Chordoma, Kidney Cancer, Leukemia, Lymphoma, Mucositis, Neuroblastoma, Pain, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: polyvinylpyrrolidone-sodium hyaluronate gel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer, including, but not limited to, the following: Acute lymphoblastic leukemia Acute myeloid leukemia Brain tumor Hodgkin's lymphoma Non-Hodgkin's lymphoma Sarcoma Wilms' tumor Neuroblastoma Meets 1 of the following criteria: Admitted to an in-patient unit after undergoing chemotherapy that is anticipated to cause oral mucositis Admitted to an in-patient unit after undergoing myeloablative therapy followed by peripheral blood stem cell or bone marrow transplantation Is experiencing oral pain due to mucositis PATIENT CHARACTERISTICS: No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent analgesics allowed

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: polyvinylpyrrolidone-sodium hyaluronate gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing and intensity of oral pain |  |  | 
| Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel |  |  | 
| Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel |  |  | 
| Symptoms, other than pain, considered important to the pediatric population |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, unspecified childhood solid tumor, protocol specific, childhood acute lymphoblastic leukemia, childhood Hodgkin lymphoma, chondrosarcoma, osteosarcoma, childhood soft tissue sarcoma, Wilms tumor and other childhood kidney tumors, neuroblastoma, childhood acute myeloid leukemia/other myeloid malignancies, childhood large cell lymphoma, childhood lymphoblastic lymphoma, childhood small noncleaved cell lymphoma, childhood rhabdomyosarcoma, childhood brain stem glioma, childhood central nervous system germ cell tumor, childhood cerebellar astrocytoma, childhood cerebral astrocytoma/malignant glioma, childhood choroid plexus tumor, childhood craniopharyngioma, childhood ependymoma, childhood medulloblastoma, childhood meningioma, childhood oligodendroglioma, childhood atypical teratoid/rhabdoid tumor, childhood spinal cord neoplasm, childhood supratentorial primitive neuroectodermal tumor, childhood visual pathway and hypothalamic glioma, chordoma, mucositis, Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)