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

Overview

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 Title of Study: “Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2009

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.

Interventions

  • Drug: polyvinylpyrrolidone-sodium hyaluronate gel

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Cancer and Leukaemia Group
  • Overall Official(s)
    • Faith Gibson, MD, , Great Ormond Street Hospital for Children NHS Foundation Trust
    • Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F, , The Christie NHS Foundation Trust

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