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
2 Years
18 Years
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
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 |
