Patient case: 4-year-old female with leukemia; genetic feature: ABL1

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

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.

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.

Eligibility: 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

Relevance to patient case: not relevant