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

NCT ID: NCT00036712

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

Brief 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.

Conditions

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

Keywords

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-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; childhood myelodysplastic syndromes

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

management of therapy complications

Intervention Type: PROCEDURE

pain therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Medical College of Wisconsin Cancer Center

Principal Investigators

Harry T. Whelan, MD

Role: STUDY_CHAIR

Medical College of Wisconsin

Locations

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Clinical Trials Office - Medical College of Wisconsin Cancer C

Role: primary

Other Identifiers

MCW-HRRC-28600

Identifier Type: -

Identifier Source: secondary_id

MCW-CHW-0070

Identifier Type: -

Identifier Source: secondary_id

NCI-V02-1699

Identifier Type: -

Identifier Source: secondary_id

CDR0000069293

Identifier Type: -

Identifier Source: org_study_id