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

Medical College of Wisconsin

Status and phase: Unknown; Phase 2

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

Treatments: Procedure: management of therapy complications; Procedure: pain therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00036712

MCW-CHW-0070

CDR0000069293

NCI-V02-1699

MCW-HRRC-28600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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