Status:
UNKNOWN
Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Chordoma
Eligibility:
All Genders
4-19 years
Phase:
NA
Brief Summary
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...
Detailed Description
OBJECTIVES: * Examine the feasibility and acceptability of polyvinylpyrrolidone-sodium hyaluronate gel in pediatric patients experiencing oral pain from mucositis after cancer therapy. OUTLINE: This...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00349024
Start Date
July 1 2005
Last Update
September 20 2013
Active Locations (21)
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1
Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
2
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
3
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
4
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ