Clinical trial NCT06623305: A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer
Official title: Photobiomodulation Therapy for the Prevention and Treatment of Mucositis in Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mucositis Oral
Keywords: Photobiomodulation
Mucositis
Oral Mucositis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 50
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective - Retrospective Longitudinal Study
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Secondary outcomes:
measure: Evaluate the effectiveness of using PBM based on mucositis onset
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on mucositis severity.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on mucositis duration.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on length of stay.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on narcotic usage.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on nutritional support.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on pain score.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on MBI CLABSI rate.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
measure: Evaluate the effectiveness of using PBM based on Glutamine administration.
timeFrame: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
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