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

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
Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Oral Complications of Cancer and Cancer Therapy 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:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00036712
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent childhood acute lymphoblastic leukemia

refractory plasma cell neoplasm

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 of cancer and cancer therapy

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, 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, Myeloid, Chronic, Atypical, BCR-ABL Negative

Blood Coagulation Disorders

Acute promyelocytic leukemia

Acute myelogenous leukemia

Genital Neoplasms, Female

Myeloproliferative Disorders

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Neoplasms by Site

Neoplasms by Histologic Type

Immune System Diseases

Blood Protein Disorders

Syndrome

Neoplasms, Nerve Tissue

Cardiovascular Diseases

Neoplasms, Neuroepithelial

Adnexal Diseases

ClinicalTrials.gov processed this record on September 04, 2008

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