Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation - Full Text View

Sponsored by:	Medical College of Wisconsin
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00036712

Purpose

RATIONALE: Light-emitting diode (LED) therapy may be able to prevent mucositis of the mouth.

PURPOSE: Randomized phase II trial to determine the effectiveness of LED therapy in preventing mucositis of the mouth in children who are receiving chemotherapy with or without radiation therapy before donor bone marrow transplantation.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Pain Sarcoma	Procedure: management of therapy complications Procedure: pain therapy	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Bone Marrow Transplantation Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Supportive Care

Official Title:

A Multiinstitutional Trial To Evaluate The Prophylactic Use Of NASA-Developed Light Emitting Diodes For The Prevention Of Oral Mucositis In Bone Marrow Transplant Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
Mean change in pain score from baseline to maximum score within 14 days posttransplant
Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant

Secondary Outcome Measures:

Time to heal

Estimated Enrollment:

80

Study Start Date:

January 2002

Detailed Description:

OBJECTIVES:

Compare the incidence and severity of oral mucositis in children undergoing NASA-developed light-emitting diode (LED) therapy during a pre-transplantation myeloablative conditioning regimen (chemotherapy with or without radiotherapy) and continuing through the post-bone marrow transplantation (BMT) phase versus LED therapy during the post-BMT phase only.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center and cheek being treated (right vs left). Patients are randomized to 1 of 2 schedules of light-emitting diode (LED) therapy.

Arm I: Patients undergo LED therapy for 71 seconds once daily beginning on day 1 of the myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy and continuing for 14 days after bone marrow transplantation (BMT).
Arm II: Patients undergo LED therapy as in arm I beginning on the day of BMT (day 0) and continuing for 14 days after BMT.

Photographs are taken of the right and left buccal mucosa at baseline and then every 3 days beginning on day 1 of LED therapy.

Pain and xerostomia are assessed using the Wong-Baker "smiley-face" pain scale at baseline and then periodically for 14 days after BMT.

Patients are followed monthly for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:

2 Years to 18 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Patients undergoing a myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy prior to a first allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

2 to 18

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Pulmonary:

No pulmonary dysfunction that would increase significantly the risk of requiring intubation during the first 21 days after transplantation

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No photophobia
Must have emotional, cognitive, and mental maturity sufficient to tolerate light-emitting diode therapy application and oral examination without combativeness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Other:

No concurrent medication that may cause epidermal or ocular photosensitivity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036712

Locations

United States, Wisconsin
Medical College of Wisconsin Cancer Center	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Study Chair:

Harry T. Whelan, MD

Medical College of Wisconsin

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:

CDR0000069293, MCW-HRRC-28600, MCW-CHW-0070, NCI-V02-1699

First Received:

May 13, 2002

Last Updated:

November 13, 2008

ClinicalTrials.gov Identifier:

NCT00036712

Health Authority:

Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent childhood acute lymphoblastic leukemia
refractory multiple myeloma
recurrent childhood rhabdomyosarcoma
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
recurrent childhood lymphoblastic lymphoma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia

chronic idiopathic myelofibrosis
childhood acute promyelocytic leukemia (M3)
refractory hairy cell leukemia
oral complications
recurrent/refractory childhood Hodgkin lymphoma
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
pain
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
previously treated childhood rhabdomyosarcoma
childhood malignant ovarian germ cell tumor
childhood chronic myelogenous leukemia
atypical chronic myeloid leukemia

Study placed in the following topic categories:

Blast Crisis
Neuroectodermal Tumors, Primitive
Chronic myelogenous leukemia
Malignant mesenchymal tumor
Urogenital Neoplasms
Urologic Neoplasms
Small non-cleaved cell lymphoma
Preleukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Neuroepithelioma
Kidney Diseases

Hodgkin Disease
Endocrine Gland Neoplasms
Rhabdomyosarcoma
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Mucositis
Hematologic Diseases
Leukemia, B-cell, chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Acute promyelocytic leukemia
Acute myelogenous leukemia

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases

Syndrome
Neoplasms, Nerve Tissue
Cardiovascular Diseases
Neoplasms, Neuroepithelial
Adnexal Diseases

ClinicalTrials.gov processed this record on January 07, 2009