Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 41
- Primary Endpoint
- Timing and intensity of oral pain
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Timing and intensity of oral pain
Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
Symptoms, other than pain, considered important to the pediatric population
Secondary Outcomes
No secondary outcomes reported