This trial is active, not recruiting.

Conditions brain and central nervous system tumors, chordoma, kidney cancer, leukemia, lymphoma, mucositis, neuroblastoma, pain, sarcoma, unspecified childhood solid tumor, protocol specific
Treatment polyvinylpyrrolidone-sodium hyaluronate gel
Sponsor Children's Cancer and Leukaemia Group
Start date July 2005
End date December 2009
Trial size 50 participants
Trial identifier NCT00349024, CCLG-SC-2005-07, CDR0000481526, EU-20621


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose supportive care

Primary Outcomes

Timing and intensity of oral pain
time frame:
Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
time frame:
Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
time frame:
Symptoms, other than pain, considered important to the pediatric population
time frame:

Eligibility Criteria

Male or female participants from 4 years up to 19 years old.

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

Additional Information

Official title Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).