Light therapy may soothe chemo mouth sores in children
NCT ID NCT07372443
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if a special light (photobiomodulation) can prevent and treat painful mouth sores caused by chemotherapy in children aged 4-17 with cancer. Half of the 49 participants will get light therapy, and the other half will get a standard gel. The goal is to see if the light reduces soreness, pain, and healing time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- photobiomodulation (low-level light therapy)
- What this could lead to
- If it works, this could offer a non-drug way to prevent and treat painful mouth sores in children undergoing chemotherapy, improving their quality of life.
- What could go wrong
- This is a small, early-stage trial with only 49 participants, so results may not apply to all children. The light therapy may not work better than the standard gel, and the study hasn't started yet.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Prevention Arm - Inclusion Criteria * Age 4 to 17 years * Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck. * Within days 1-3 of the start of any chemotherapy cycle; for leukemia patients, in consolidation phase as defined by protocol. * No signs of oral mucositis at enrollment. * Availability and willingness to attend scheduled photobiomodulation (PBM) application sessions. * Parent/legal guardian signed informed consent and child assent when applicable (≥ 8 years). * No documented primary immunodeficiency. * No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation. * No PBM treatment within 14 days prior to enrollment. * No history of adverse reactions to light therapies or known photosensitivity. * No history of seizure disorder or diagnosis of epilepsy. Treatment Arm - Inclusion Criteria * Age 4 to 17 years * Histopathologic diagnosis of malignant neoplasm: leukemia, lymphoma, or solid tumor of the head and neck. * Currently receiving chemotherapy (any cycle of the regimen). * Presence of oral mucositis of any grade during chemotherapy, identified within the first 3 days from onset of the mucositis episode. * Parent/legal guardian signed informed consent and child assent when applicable (≥ 8 years). * No documented primary immunodeficiency. * No severe concomitant systemic infection or medical condition that, in the investigator's judgment, contraindicates participation. * No photobiomodulation (PBM) treatment within 14 days prior to enrollment. * No history of adverse reactions to light therapies or known photosensitivity. * No history of seizure disorder or diagnosis of epilepsy. Exclusion Criteria: * Documented primary immunodeficiency. * Severe concomitant systemic infection or unstable medical condition. * PBM treatment within 14 days prior to enrollment. * Known photosensitivity or prior adverse reaction to light therapy. * History of seizures or epilepsy. * Any condition that, in the investigator's opinion, would interfere with study participation or safety. Participant Withdrawal Criteria * Attendance to fewer than 80% of scheduled treatment sessions. * Any adverse event or persistent discomfort attributed to PBM that leads the participant or guardian to decline further intervention. * Withdrawal of consent by parent/guardian or assent withdrawal by participant when applicable. * Development of a new medical condition that, per investigator judgment, contraindicates continuation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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