Chronic Myeloproliferative DisordersPhase 2NCT00036712
Light-Emitting Diode Therapy in Preventing Mucositis in Children Receiving Chemotherapy With or Without Radiation Therapy Before Bone Marrow Transplantation
A Phase 2 study testing management of therapy complications and pain therapy in people with Chronic Myeloproliferative Disorders and Kidney Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Kidney Cancer, Leukemia
- What is being tested?
- management of therapy complications and pain therapy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Aug 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Clinical Trials Office - Medical College of Wisconsin Cancer C, 414-805-4380
About this study
Official title: 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
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.
Read the 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
- Being tested
- management of therapy complications, pain therapy
- 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
- Medical subject headings
- Myeloproliferative Disorders, Kidney Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
pain therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
Mean change in pain score from baseline to maximum score within 14 days posttransplant
Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant
Secondary outcomes (1)
Time to heal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Investigators
- Harry T. Whelan, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036712
- Sponsor's protocol ID
- CDR0000069293
- Other IDs
- MCW-HRRC-28600, MCW-CHW-0070, NCI-V02-1699
- Status last verified
- Jun 2009
- First submitted
- 13 May 2002
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00036712
- Acronym / sponsor ID
- CDR0000069293
- Conditions
- Chronic Myeloproliferative Disorders, Kidney Cancer, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Aug 2009 (estimated)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
| pain therapy | Procedure or surgery | – |
Primary outcome
Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant
Mean change in pain score from baseline to maximum score within 14 days posttransplant
Proportion of patients not experiencing ulcerative mucositis within the first 14 days posttransplant
1 secondary outcome
Time to heal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry T. Whelan, MD study chair
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing management of therapy complications and pain therapy in people with Chronic Myeloproliferative Disorders and Kidney Cancer, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in oral mucositis index (OMI) score from baseline to maximum score within 14 days posttransplant. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.