Back to resultsPolyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Primary Purpose
Brain and Central Nervous System Tumors, Chordoma, Kidney Cancer
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
polyvinylpyrrolidone-sodium hyaluronate gel
Sponsored by
About this trial
This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring unspecified childhood solid tumor, protocol specific, pain, 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)
Eligibility Criteria
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
Sites / Locations
- Our Lady's Hospital for Sick Children Crumlin
- Birmingham Children's Hospital
- Institute of Child Health at University of Bristol
- Addenbrooke's Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Leicester Royal Infirmary
- Royal Liverpool Children's Hospital, Alder Hey
- Middlesex Hospital
- Great Ormond Street Hospital for Children
- Royal Manchester Children's Hospital
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
- Queen's Medical Centre
- Oxford Radcliffe Hospital
- Children's Hospital - Sheffield
- Southampton General Hospital
- Royal Marsden - Surrey
- Royal Belfast Hospital for Sick Children
- Royal Aberdeen Children's Hospital
- Royal Hospital for Sick Children
- Royal Hospital for Sick Children
- Childrens Hospital for Wales
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00349024
First Posted
July 5, 2006
Last Updated
September 19, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00349024
Brief Title
Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Official Title
Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. Study Description
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 well polyvinylpyrrolidone-sodium hyaluronate gel works in reducing pain from oral mucositis in young patients with cancer.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Chordoma, Kidney Cancer, Leukemia, Lymphoma, Mucositis, Neuroblastoma, Pain, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
unspecified childhood solid tumor, protocol specific, pain, 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)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
polyvinylpyrrolidone-sodium hyaluronate gel
Primary Outcome Measure Information:
Title
Timing and intensity of oral pain
Title
Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
Title
Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
Title
Symptoms, other than pain, considered important to the pediatric population
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith Gibson, MD
Organizational Affiliation
Great Ormond Street Hospital for Children NHS Foundation Trust
First Name & Middle Initial & Last Name & Degree
Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F
Organizational Affiliation
The Christie NHS Foundation Trust
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children Crumlin
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
W1T 3AA
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
12. IPD Sharing Statement
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Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
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