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| Sponsored by: |
Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00349024 |
Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Open Label, Uncontrolled |
| Official Title: | Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07) |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 4 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of cancer, including, but not limited to, the following:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom, England | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Middlesex Hospital | |
| London, England, United Kingdom, W1T 3AA | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| United Kingdom, Scotland | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| United Kingdom, Wales | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
| Investigator: | Faith Gibson, MD | Great Ormond Street Hospital for Children |
| Investigator: | Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F | Christie Hospital NHS Foundation Trust |
More Information
| Study ID Numbers: | CDR0000481526, CCLG-SC-2005-07, EU-20621 |
| Study First Received: | July 5, 2006 |
| Last Updated: | July 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00349024 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Mouth Diseases Neuroectodermal Tumors, Primitive Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Neoplasms, Connective and Soft Tissue Acute Myelocytic Leukemia Wilms' Tumor Osteogenic Sarcoma Neuroepithelioma Glioma Kidney Diseases Hodgkin Disease Nervous System Neoplasms Rhabdomyosarcoma |
Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Astrocytoma Mucositis Stomatitis Adjuvants, Immunologic Myeloproliferative Disorders Leukemia, Myeloid Ewing's Sarcoma Carcinoma Neuroectodermal Tumors Brain Stem Glioma, Childhood Malignant Mesenchymal Tumor Sarcoma |
|
Mouth Diseases Neuroectodermal Tumors, Primitive Immunologic Factors Hyaluronic Acid Gastrointestinal Diseases Physiological Effects of Drugs Hematologic Agents Neoplasms, Nerve Tissue Urogenital Neoplasms Central Nervous System Neoplasms Urologic Neoplasms Chordoma Neuroblastoma Neoplasms, Connective and Soft Tissue Leukemia |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Blood Substitutes Povidone Kidney Diseases Lymphoma Nervous System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Stomatitis Mucositis |
