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Trial Title:
A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer
NCT ID:
NCT06623305
Condition:
Mucositis Oral
Conditions: Official terms:
Mucositis
Stomatitis
Conditions: Keywords:
Photobiomodulation
Mucositis
Oral Mucositis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective - Retrospective Longitudinal Study
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Photobiomodulation
Description:
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.
Arm group label:
Prospective Arm
Other name:
PBM
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unwilling to participate
- Do not meet eligibility criteria outline above
Gender:
All
Minimum age:
N/A
Maximum age:
30 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Contact:
Last name:
Elissa Shulta, DNP
Phone:
414-266-5407
Email:
EShulta@childrenswi.org
Contact backup:
Last name:
Peter Shaw, MD
Phone:
414-955-4086
Email:
pshaw@mcw.edu
Investigator:
Last name:
Peter Shaw, MD
Email:
Sub-Investigator
Investigator:
Last name:
Valerie Lohse, MSN
Email:
Sub-Investigator
Investigator:
Last name:
Cynthia Flanagan, BSN
Email:
Sub-Investigator
Investigator:
Last name:
Elissa Shulta, DNP
Email:
Principal Investigator
Start date:
February 2025
Completion date:
December 2025
Lead sponsor:
Agency:
Medical College of Wisconsin
Agency class:
Other
Source:
Medical College of Wisconsin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06623305
