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

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00349024

Collaborator

(none)

Enrollment

Locations

2.4

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Chordoma Kidney Cancer Leukemia Lymphoma Mucositis Neuroblastoma Pain Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific	Drug: polyvinylpyrrolidone-sodium hyaluronate gel	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2005

Anticipated Primary Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospital for Sick Children Crumlin	Dublin		Ireland	12
2	Birmingham Children's Hospital	Birmingham	England	United Kingdom	B4 6NH
3	Institute of Child Health at University of Bristol	Bristol	England	United Kingdom	BS2 8AE
4	Addenbrooke's Hospital	Cambridge	England	United Kingdom	CB2 2QQ
5	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
6	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
7	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England	United Kingdom	L12 2AP
8	Middlesex Hospital	London	England	United Kingdom	W1T 3AA
9	Great Ormond Street Hospital for Children	London	England	United Kingdom	WC1N 3JH
10	Royal Manchester Children's Hospital	Manchester	England	United Kingdom	M27 4HA
11	Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Newcastle-Upon-Tyne	England	United Kingdom	NE1 4LP
12	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
13	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 9DU
14	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
15	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
16	Royal Marsden - Surrey	Sutton	England	United Kingdom	SM2 5PT
17	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland	United Kingdom	BT12 6BE
18	Royal Aberdeen Children's Hospital	Aberdeen	Scotland	United Kingdom	AB25 2ZG
19	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom	EH9 1LF
20	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ
21	Childrens Hospital for Wales	Cardiff	Wales	United Kingdom	CF14 4XW

Sponsors and Collaborators

Children's Cancer and Leukaemia Group

Investigators

: 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