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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. completion date
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


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
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