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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Myeloproliferative Disorders, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neuroblastoma, Oral Complications, Ovarian Cancer, Pain, Sarcoma

Intervention / Treatment
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* Procedure: management of therapy complications
* Procedure: pain therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|nan|
|Procedure: pain therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heal |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, primary 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, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes