- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00036712
Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 |
---|
Time to heal
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- pain
- primary myelofibrosis
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent/refractory childhood Hodgkin lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- oral complications
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- disseminated neuroblastoma
- recurrent neuroblastoma
- refractory multiple myeloma
- refractory hairy cell leukemia
- recurrent childhood acute lymphoblastic leukemia
- accelerated phase chronic myelogenous leukemia
- recurrent childhood acute myeloid leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- recurrent childhood lymphoblastic lymphoma
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- recurrent Wilms tumor and other childhood kidney tumors
- childhood acute promyelocytic leukemia (M3)
- childhood malignant ovarian germ cell tumor
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms, Glandular and Epithelial
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Gastrointestinal Diseases
- Hemorrhagic Disorders
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Mucositis
- Neuroblastoma
- Plasmacytoma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Other Study ID Numbers
- CDR0000069293
- MCW-HRRC-28600
- MCW-CHW-0070
- NCI-V02-1699
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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