Pain Clinical Trial
Official title:
Efficacy of Gelclairâ„¢ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Verified date | June 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 19 Years |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Ireland | Our Lady's Hospital for Sick Children Crumlin | Dublin | |
United Kingdom | Royal Aberdeen Children's Hospital | Aberdeen | Scotland |
United Kingdom | Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland |
United Kingdom | 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 | Childrens Hospital for Wales | Cardiff | Wales |
United Kingdom | Royal Hospital for Sick Children | Edinburgh | Scotland |
United Kingdom | Royal Hospital for Sick Children | Glasgow | Scotland |
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 | Great Ormond Street Hospital for Children | London | England |
United Kingdom | Middlesex Hospital | 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 |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer and Leukaemia Group |
Ireland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Timing and intensity of oral pain | |||
Primary | Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel | |||
Primary | Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel | |||
Primary | Symptoms, other than pain, considered important to the pediatric population |
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