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Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
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.
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.
Age
4 - 19 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 1, 2005
Primary Completion Date
December 1, 2009
Last Updated
September 20, 2013
50
ESTIMATED participants
polyvinylpyrrolidone-sodium hyaluronate gel
DRUG
Lead Sponsor
Children's Cancer and Leukaemia Group
NCT07485114
NCT00026884
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