Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
NCT ID: NCT00349024
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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SUPPORTIVE_CARE
NONE
Interventions
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polyvinylpyrrolidone-sodium hyaluronate gel
Eligibility Criteria
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Inclusion Criteria
* 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
4 Years
19 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Faith Gibson, MD
Role:
Great Ormond Street Hospital for Children NHS Foundation Trust
Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F
Role:
The Christie NHS Foundation Trust
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Middlesex Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CCLG-SC-2005-07
Identifier Type: -
Identifier Source: secondary_id
EU-20621
Identifier Type: -
Identifier Source: secondary_id
CDR0000481526
Identifier Type: -
Identifier Source: org_study_id