A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer
- Conditions
- Mucositis Oral
- Interventions
- Device: Photobiomodulation
- Registration Number
- NCT06623305
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
The goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. The main questions it aims to answer are:
Is it reasonable and acceptable to provide light therapy for children with cancer?
Does light therapy prevent and treat mouth sores related to medical treatment?
Researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis.
Participants will:
* Tell the nurse their pain score, related to their mouth sores, before receiving light therapy.
* Have picture taken of their mouth to look for mouth sores.
* Receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Admitted to oncology unit, PICU, or on an alternate acute care unit.
- Diagnosis:
- Following diagnoses until achieve count recover (ANC≥500), the patient has no clinical signs of mucositis, or is discharged i. ALL interim-maintenance high dose Methotrexate ii. ALL with trisomy 21 receiving high dose Methotrexate iii. AML iv. Neuroblastoma (excluding admissions for antibody treatment) v. Burkitt lymphoma vi. Osteosarcoma receiving high dose Methotrexate vii. Germ cell tumors receiving Etoposide viii. Rhabdomyosarcoma ix. Ewing sarcoma
- Head/neck cancers receiving radiation
- Able to speak and understand English or Spanish
- Unwilling to participate
- Do not meet eligibility criteria outline above
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prospective Arm Photobiomodulation Prospective data review of patients who receive light therapy
- Primary Outcome Measures
Name Time Method Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed through a questionnaire completed by the RN administering the PBM therapy and will focus on the patient's tolerance level rated on a numerical scale, the nurse's perception of feasibility, and length of treatment in minutes.
- Secondary Outcome Measures
Name Time Method Evaluate the effectiveness of using PBM based on mucositis onset From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record based on the first day a patient has reported oral mucosal pain or oral ulcers/sloughing.
Evaluate the effectiveness of using PBM based on mucositis severity. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined using the CTCAE oral mucositis grading scale.
Evaluate the effectiveness of using PBM based on mucositis duration. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the first day a patient has reported oral mucosal pain or oral ulcers/sloughing until the patient no longer reports oral mucosal pain or no longer has clinical signs of mucositis.
Evaluate the effectiveness of using PBM based on length of stay. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the period of time between the patient's admission date and their discharge date.
Evaluate the effectiveness of using PBM based on narcotic usage. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as any narcotic administration documented in the Medication Administration Record, such as PRN narcotics (PO or IV), scheduled narcotics, or use of Patient-Controlled Analgesic.
Evaluate the effectiveness of using PBM based on nutritional support. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the administration of TPN or lipids as documented in the Medication Administration Record.
Evaluate the effectiveness of using PBM based on pain score. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the numeral rating that patient provides to the PBM RN using an age-appropriate pain scale specifically related to oral or throat pain.
* 0 - 10: Verbal Numeric Rating Scale (VNRS)- Use for children ≥8 years old who understand the concept of order and number
* Bieri Faces- Use for children \> 3 years old who can understand the scale
* FLACC - Revised (Face- Legs- Activity- Cry- Consolability)- Use for infants, toddlers, children with developmental delay, or any child who is unable to use a self-report scale (0-10 or Bieri faces)Evaluate the effectiveness of using PBM based on MBI CLABSI rate. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as the rate of MBI CLABSIs per 1,000 line days.
Evaluate the effectiveness of using PBM based on Glutamine administration. From date of enrollment until date of last PBM treatment, assessed up to 2 years. This will be assessed by the study team through analysis of retrospective and prospective data entered into the electronic health record, defined as a documented administration as "given" in the Medication Administration Record for oral glutamine in the past 24 hours.
Trial Locations
- Locations (1)
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States