Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
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ClinicalTrials.gov Identifier: NCT00036712 |
Recruitment Status
: Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted
: January 27, 2003
Last Update Posted
: September 20, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Procedure: management of therapy complications Procedure: pain therapy | Phase 2 |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Primary Purpose: | 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 |
Study Start Date : | January 2002 |
Estimated Primary Completion Date : | August 2009 |

- 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
- Time to heal

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036712
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 |
Study Chair: | Harry T. Whelan, MD | Medical College of Wisconsin |
Responsible Party: | Harry T. Whelan, Medical College of Wisconsin Cancer Center |
ClinicalTrials.gov Identifier: | NCT00036712 History of Changes |
Other Study ID Numbers: |
CDR0000069293 MCW-HRRC-28600 MCW-CHW-0070 NCI-V02-1699 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 20, 2013 |
Last Verified: | June 2009 |
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 |
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 |
Additional relevant MeSH terms:
Lymphoma Syndrome Leukemia Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Neuroblastoma Kidney Neoplasms Carcinoma, Renal Cell Mucositis Myeloproliferative Disorders Plasmacytoma Myelodysplastic-Myeloproliferative Diseases |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases |