Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Active	2 to 18	Other	MCW-HRRC-28600 MCW-CHW-0070, NCI-V02-1699, NCT00036712

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Patients undergoing a myeloablative conditioning regimen comprising chemotherapy with or without radiotherapy prior to a first allogeneic bone marrow transplantation

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

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

Expected Enrollment

A total of 80 patients (40 per arm) will be accrued for this study within 2 years.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Medical College of Wisconsin Cancer Center

Harry Whelan, MD, Protocol chair		Ph: 414-266-7544 Email: hwhelan@mcw.edu

U.S.A.
Wisconsin
	Milwaukee
	Medical College of Wisconsin Cancer Center
		Clinical Trials Office - Medical College of Wisconsin Cancer Center	Ph:  414-805-4380

Registry Information
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
Trial Start Date		2002-01-01
Trial Completion Date		2009-08-02 (estimated)
Registered in ClinicalTrials.gov		NCT00036712
Date Submitted to PDQ		2002-02-08
Information Last Verified		2009-06-07

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