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

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00349024
• Other study ID #: CDR0000481526
• Secondary ID: CCLG-SC-2005-07E
• Status: Active, not recruiting
• Phase: N/A
• First received: July 5, 2006
• Last updated: September 19, 2013
• Start date: July 2005

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 19 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chordoma
• Kidney Cancer
• Leukemia
• Lymphoma
• Mucositis
• Nervous System Neoplasms
• Neuroblastoma
• Pain
• Sarcoma
• Stomatitis
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Drug:
• polyvinylpyrrolidone-sodium hyaluronate gel

Locations

Country	Name	City	State
Ireland	Our Lady's Hospital for Sick Children Crumlin	Dublin
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Scotland
United Kingdom	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Institute of Child Health at University of Bristol	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Childrens Hospital for Wales	Cardiff	Wales
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children	London	England
United Kingdom	Middlesex Hospital	London	England
United Kingdom	Royal Manchester Children's Hospital	Manchester	England
United Kingdom	Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Newcastle-Upon-Tyne	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing and intensity of oral pain
Primary	Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
Primary	Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
Primary	Symptoms, other than pain, considered important to the pediatric population