Mucositis Oral
Conditions
Keywords
Photobiomodulation, Mucositis, Oral Mucositis
Brief summary
The goal of this clinical trial is to learn if light therapy can prevent 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 mouth sores related to medical treatment? Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis. Participants will: * Complete a survey. * Have picture taken of their mouth to look for mouth sores. * Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
Interventions
DEVICEPhotobiomodulation for prevention arm
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients \<7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
DEVICEPhotobiomodulation for exploratory arm
Light therapy will be administered using the cluster probe on the external cheeks bilaterally and intraorally using the lollipop probe for patients ≥7 years of age. Patients \<7 years of age will not receive intraoral treatment with the lollipop. Instead, they will be asked to open their mouth while the covered cluster probe is held externally to treat their intraoral membranes. Each treatment (both external cheeks and intraoral buccal region) will be administered over 1 min with a Modulation Frequency 2.5Hz, Skin Conduction nS 001, and Beam Power mW 000, for a total treatment time of 3 minutes. Patients will continue to receive light therapy in the home setting through day +8 of their chemotherapy cycle using the Luminance Device.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multi-arm, prospective, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Current and new diagnosis patients consented upon admission if deemed eligible 2. Ages 0-30 3. Admitted to CW oncology/BMT inpatient unit, PICU, or West 5 4. Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2 5. Able to speak and understand English or Spanish
Exclusion criteria
1. Patients admitted on BMT service 2. Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasibility of using PBM in pediatric oncology patients. | From date of enrollment until date of last PBM treatment, assessed up to 2 years. | Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible. |
| Evaluate the acceptability of using PBM in pediatric oncology patients. | From date of enrollment until date of last PBM treatment, assessed up to 2 years. | Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of using PBM in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy. | 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 number of unique patients with the value of "mucositis/stomatitis" in the oral mucosa flowsheet row. Additionally, mucositis onset, severity, and grade will be measured using the CTCAE grading scale and the ChIMES patient/caregiver survey |
| 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. |
Countries
United States
Contacts
CONTACTElissa Shulta, DNP
CONTACTPeter Shaw, MD
Outcome results
None listed