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

NCT00349024 | Unknown

• 3 other identifiers: CDR0000481526CCLG-SC-2005-07EU-20621
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 21

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.

Conditions

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)

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

polyvinylpyrrolidone-sodium hyaluronate gel DRUG

Eligibility Criteria

• Age: 4 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Chordoma; Kidney Neoplasms; Leukemia; Lymphoma; Mucositis; Neuroblastoma; Pain; Sarcoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Chondrosarcoma; Osteosarcoma; Wilms Tumor; Dendritic Cell Sarcoma, Interdigitating; Burkitt Lymphoma; Astrocytoma; Choroid Plexus Neoplasms; Familial ependymoma; Medulloblastoma; Meningioma; Oligodendroglioma; Rhabdoid Tumor; Spinal Cord Neoplasms; Optic Nerve Glioma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Gelclair

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Leukemia, Lymphoid; Neoplasms, Connective Tissue; Neoplasms, Bone Tissue; Neoplasms, Complex and Mixed; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Histiocytic Disorders, Malignant; Histiocytosis; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Glioma; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Spinal Cord Diseases; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Study Officials

• Faith Gibson, MD

  Great Ormond Street Hospital for Children NHS Foundation Trust

• Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F

  The Christie NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: July 1, 2005
• Primary Completion: December 1, 2009
• Last Updated: September 20, 2013

Record last verified: 2009-06

Locations

GB (20); IE (1)