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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG-SC-2005-07 | |||
| EU-20621 |
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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:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyvinylpyrrolidone-sodium hyaluronate gel | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of cancer, including, but not limited to, the following:
Meets 1 of the following criteria:
Is experiencing oral pain due to mucositis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Our Lady's Hospital for Sick Children Crumlin | Dublin | 12 | Ireland | |||
| Birmingham Children's Hospital |
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| Birmingham |
| England |
| B4 6NH |
| United Kingdom |
| Institute of Child Health at University of Bristol | Bristol | England | BS2 8AE | United Kingdom |
| Addenbrooke's Hospital | Cambridge | England | CB2 2QQ | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | England | LE1 5WW | United Kingdom |
| Royal Liverpool Children's Hospital, Alder Hey | Liverpool | England | L12 2AP | United Kingdom |
| Middlesex Hospital | London | England | W1T 3AA | United Kingdom |
| Great Ormond Street Hospital for Children | London | England | WC1N 3JH | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | England | M27 4HA | United Kingdom |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | Newcastle upon Tyne | England | NE1 4LP | United Kingdom |
| Queen's Medical Centre | Nottingham | England | NG7 2UH | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 9DU | United Kingdom |
| Children's Hospital - Sheffield | Sheffield | England | S10 2TH | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| Royal Marsden - Surrey | Sutton | England | SM2 5PT | United Kingdom |
| Royal Belfast Hospital for Sick Children | Belfast | Northern Ireland | BT12 6BE | United Kingdom |
| Royal Aberdeen Children's Hospital | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
| Royal Hospital for Sick Children | Edinburgh | Scotland | EH9 1LF | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | Scotland | G3 8SJ | United Kingdom |
| Childrens Hospital for Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D002817 | Chordoma |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D052016 | Mucositis |
| D009447 | Neuroblastoma |
| D010146 | Pain |
| D012509 | Sarcoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002813 | Chondrosarcoma |
| D012516 | Osteosarcoma |
| D009396 | Wilms Tumor |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D002051 | Burkitt Lymphoma |
| D001254 | Astrocytoma |
| D016545 | Choroid Plexus Neoplasms |
| C531673 | Familial ependymoma |
| D008527 | Medulloblastoma |
| D008579 | Meningioma |
| D009837 | Oligodendroglioma |
| D018335 | Rhabdoid Tumor |
| D013120 | Spinal Cord Neoplasms |
| D020339 | Optic Nerve Glioma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D007945 | Leukemia, Lymphoid |
| D009372 | Neoplasms, Connective Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D005910 | Glioma |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D013118 | Spinal Cord Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C439265 | Gelclair |
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