A Clinical Trial of the Administration of Light Therapy to Prevent and Treat Mouth Sores in Children With Cancer (PBM)

Medical College of Wisconsin

Status: Begins enrollment in 1 month

Conditions: Mucositis Oral

Treatments: Device: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06623305

PRO00051962

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Retrospective Arm

No Intervention group

Description:

Retrospective data review of patients who did not receive light therapy

Prospective Arm

Active Comparator group

Description:

Prospective data review of patients who receive light therapy

Treatment:

Device: Photobiomodulation