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Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00349024
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 6, 2006
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Chordoma Kidney Cancer Leukemia Lymphoma Mucositis Neuroblastoma Pain Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific Drug: polyvinylpyrrolidone-sodium hyaluronate gel Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Study Start Date : July 2005
Estimated Primary Completion Date : December 2009

Primary Outcome Measures :
  1. Timing and intensity of oral pain
  2. Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
  3. Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
  4. Symptoms, other than pain, considered important to the pediatric population

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel


  • See Disease Characteristics
  • Concurrent analgesics allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00349024

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Our Lady's Hospital for Sick Children Crumlin
Dublin, Ireland, 12
United Kingdom
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
Institute of Child Health at University of Bristol
Bristol, England, United Kingdom, BS2 8AE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP
Middlesex Hospital
London, England, United Kingdom, W1T 3AA
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, England, United Kingdom, M27 4HA
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Queen's Medical Centre
Nottingham, England, United Kingdom, NG7 2UH
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DU
Children's Hospital - Sheffield
Sheffield, England, United Kingdom, S10 2TH
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom, BT12 6BE
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom, G3 8SJ
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
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OverallOfficial: Faith Gibson, MD Great Ormond Street Hospital for Children NHS Foundation Trust
OverallOfficial: Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F The Christie NHS Foundation Trust

Layout table for additonal information Identifier: NCT00349024     History of Changes
Other Study ID Numbers: CDR0000481526
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific
childhood acute lymphoblastic leukemia
childhood Hodgkin lymphoma
childhood soft tissue sarcoma
Wilms tumor and other childhood kidney tumors
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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Nervous System Diseases