Pain Clinical Trial
Official title:
Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
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.
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.
;
Masking: Open Label, Primary Purpose: Supportive Care
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