Clinical trial NCT00349024: Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Official title: Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Chordoma
Kidney Cancer
Leukemia
Lymphoma
Mucositis
Neuroblastoma
Pain
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: unspecified childhood solid tumor, protocol specific
pain
childhood acute lymphoblastic leukemia
childhood Hodgkin lymphoma
chondrosarcoma
osteosarcoma
childhood soft tissue sarcoma
Wilms tumor and other childhood kidney tumors
neuroblastoma
childhood acute myeloid leukemia/other myeloid malignancies
childhood large cell lymphoma
childhood lymphoblastic lymphoma
childhood small noncleaved cell lymphoma
childhood rhabdomyosarcoma
childhood brain stem glioma
childhood central nervous system germ cell tumor
childhood cerebellar astrocytoma
childhood cerebral astrocytoma/malignant glioma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoma
childhood medulloblastoma
childhood meningioma
childhood oligodendroglioma
childhood atypical teratoid/rhabdoid tumor
childhood spinal cord neoplasm
childhood supratentorial primitive neuroectodermal tumor
childhood visual pathway and hypothalamic glioma
chordoma
mucositis
Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Timing and intensity of oral pain
measure: Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel
measure: Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel
measure: Symptoms, other than pain, considered important to the pediatric population
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospital for Sick Children Crumlin
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Institute of Child Health at University of Bristol
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital, Alder Hey
state: England
city: London
country: United Kingdom
facility: Middlesex Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
state: England
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Sir James Spence Institute of Child Health at Royal Victoria Infirmary
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Cardiff
country: United Kingdom
facility: Childrens Hospital for Wales
state: Wales
Study officials:
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Faith Gibson, MD
affiliation: The Christie NHS Foundation Trust
name: Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F
References: