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

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.

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