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

Study Description

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Brief Summary:

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

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 Design

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Time to heal

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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