Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
4 Years
19 Years
Both
Brain and Central Nervous System Tumors, Chordoma, Kidney Cancer, Leukemia, Lymphoma, Mucositis, Neuroblastoma, Pain, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Timing and intensity of oral pain
Principal Investigator
Faith Gibson, MD
Investigator Affiliation:
Great Ormond Street Hospital for Children NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000481526
NCT ID:
NCT00349024
Start Date:
July 2005
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Chordoma
- Kidney Cancer
- Leukemia
- Lymphoma
- Mucositis
- Neuroblastoma
- Pain
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
- 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)
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Chordoma
- Leukemia
- Lymphoma
- Nervous System Neoplasms
- Neuroblastoma
- Stomatitis
- Central Nervous System Neoplasms
- Mucositis
- Sarcoma
Name | Location |
|---|
