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Efficacy of Gelclairâ„¢ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)

4 Years
19 Years
Open (Enrolling)
Brain and Central Nervous System Tumors, Chordoma, Kidney Cancer, Leukemia, Lymphoma, Mucositis, Neuroblastoma, Pain, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Efficacy of Gelclairâ„¢ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)


- 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


- 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

Type of Study:


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


United States: Federal Government

Study ID:




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