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

Children's Cancer and Leukaemia Group

Status: Unknown

Conditions: Sarcoma; Neuroblastoma; Brain and Central Nervous System Tumors; Chordoma; Kidney Cancer; Lymphoma; Mucositis; Leukemia; Pain; Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Drug: polyvinylpyrrolidone-sodium hyaluronate gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00349024

EU-20621

CDR0000481526

CCLG-SC-2005-07

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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