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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


Phase 2
2 Years
18 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant

Principal Investigator

Harry T. Whelan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin

Authority:

Unspecified

Study ID:

CDR0000069293

NCT ID:

NCT00036712

Start Date:

January 2002

Completion Date:

Related Keywords:

  • 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
  • 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-ABL negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Neuroblastoma
  • Ovarian Neoplasms
  • Mucositis
  • Sarcoma
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226