Recruiting
Phase 2

LED Therapy

Sponsor:

Medical College of Wisconsin

Code:

NCT00036712

Conditions

Chronic Myeloproliferative Disorders

Kidney Cancer

Leukemia

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

management of therapy complications

pain therapy

Study Details

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.

Conditions

Chronic Myeloproliferative Disorders

Kidney Cancer

Leukemia

Lymphoma

Multiple Myeloma and Plasma Cell Neoplasm

Study ID

NCT00036712

Start date

Jan, 2002

Status verified date

Jun, 2009

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

management of therapy complications

pain therapy

Primary outcome measure

  • Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant [ Time Frame: undefined ]
  • Mean change in pain score from baseline to maximum score within 14 days posttransplant [ Time Frame: undefined ]
  • Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Medical College of Wisconsin Cancer Center

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Clinical Trials Office - Medical College of Wisconsin Cancer C

414-805-4380

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 20, 2013

Last verified

Jun, 2009

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2013-09-20.