Trials / Unknown
UnknownNCT00349024
Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Children's Cancer and Leukaemia Group · Academic / Other
- Sex
- All
- Age
- 4 Years – 19 Years
- Healthy volunteers
- Not accepted
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. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Conditions
- Brain and Central Nervous System Tumors
- Chordoma
- Kidney Cancer
- Leukemia
- Lymphoma
- Mucositis
- Neuroblastoma
- Pain
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | polyvinylpyrrolidone-sodium hyaluronate gel |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2009-12-01
- First posted
- 2006-07-06
- Last updated
- 2013-09-20
Locations
21 sites across 2 countries: Ireland, United Kingdom
Source: ClinicalTrials.gov record NCT00349024. Inclusion in this directory is not an endorsement.