Oral MucositisPBMOM-PEDMXNCT07372443
Photobiomodulation in the Prevention and Management of Oral Mucositis in Children
A study testing Photobiomodulation and bioadhesive gel in people with Oral Mucositis and Chemotherapy Effect, run by Universidad de Guanajuato.
Trial summary
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Oral Mucositis, Chemotherapy Effect, Pediatric Cancer
- What is being tested?
- Photobiomodulation and bioadhesive gel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Usefulness of Photobio-modulation in the Prevention and Management of Oral Mucositis in Pediatric Patients Undergoing Antineoplastic Treatment: Randomized Clinical Trial
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J/cm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.
Read the detailed description
Oral mucositis is a common and debilitating adverse effect in pediatric patients undergoing cancer treatment. It significantly affects quality of life, nutrition, hydration, and treatment adherence. Photobiomodulation is a promising non-invasive therapy, but there is limited evidence in the pediatric population, particularly in Mexico. Objective: To evaluate the clinical utility of FBM in the prevention and treatment of OM induced by antineoplastic therapy in pediatric cancer patients, compared to conventional treatment with bioadhesive gel. This is a randomized, single-blind clinical trial in patients aged 4 to 17 years. The design includes two arms: 1) Treatment (parallel design: FBM vs. gel for established OM) and 2) Prevention (crossover design: patients receive both interventions in successive cycles of chemotherapy). The primary outcome will be the degree of OM according to the WHO scale. FBM is expected to significantly reduce the incidence, severity, and duration of OM, as well as the intensity of pain. In addition, scientific evidence will be generated on the implementation of FBM in pediatric oncology in Mexico, with the potential to standardize protocols that improve patients' quality of life and optimize the management of oral complications of antineoplastic treatment.
- Conditions
- Oral Mucositis, Chemotherapy Effect, Pediatric Cancer
- Being tested
- Photobiomodulation, bioadhesive gel
- Keywords
- Photobiomodulation
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
For the prevention arm, photobiomodulation will be applied three alternate days per week starting on the first three days of chemotherapy. It will be applied to areas such as the corners of the mouth, the lip mucosa, the buccal mucosa, the lateral edges of the tongue, the ventral tongue, the anterior floor of the mouth, and the soft palate. For the treatment arm, photobiomodulation will be applied every other day of the week from the detection of oral mucositis until resolution. The application sites will be the affected mucosal areas, whether they present erythema or ulcerations.
bioadhesive gelDrug
Application of bioadherent gel Rinse with bioadherent gel, 5 consecutive days, 30 to 60 minutes before each meal. Or apply with a swab in young children who are unable to rinse.
| Study group | Role | What they receive |
|---|---|---|
| Prevention arm | Experimental | Cross-over design: patients receive both interventions (photobiomodulation in the first phase and are reassigned to receive bioadhesive gel in the second phase), i.e., in successive cycles of chemotherapy, within the first three days of the start of chemotherapy, in the absence of oral mucositis. Receives: Device: Photobiomodulation; Drug: bioadhesive gel |
| Treatment | Experimental | Treatment arm: randomization into two groups: one receives photobiomodulation, and the other receives bioadhesive gel, in the presence of oral mucositis. Receives: Device: Photobiomodulation; Drug: bioadhesive gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral mucositis grade
Grade of oral mucositis assessed using the World Health Organization (WHO) oral mucositis scale (0-4). Assessments performed by a blinded clinician trained in the scale
Measured: Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)
Secondary outcomes (2)
Incidence of oral mucositis
Proportion of chemotherapy cycles in which participants develop oral mucositis defined as WHO grade ≥1; assessments by blinded clinician
Measured: Per chemotherapy cycle and overall study period (up to 21 days post intervention).
Oral mucositis Duration outcome
time from onset of WHO grade ≥1 mucositis to resolution to WHO grade 0.
Measured: Mesured for each episode during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple-blind randomized clinical trial. Two arms: Treatment (parallel design). Prevention (crossover design).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Paulina Rodríguez Vargas, Universidad de Guanajuato
- Investigators
- María C Palacios, PhD, Study director, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372443
- Sponsor's protocol ID
- MX-UG-PBM-PED-2025-001
- Acronym
- PBMOM-PEDMX
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Photobio-modulation in the Prevention and Management of Oral Mucositis in Pediatric Patients Undergoing Antineoplastic Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07372443
- Acronym / sponsor ID
- PBMOM-PEDMX / MX-UG-PBM-PED-2025-001
- Conditions
- Oral Mucositis, Chemotherapy Effect, Pediatric Cancer
- Keywords
- Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral mucositis (OM) is a frequent, debilitating complication in pediatric oncology that impairs quality of life, nutrition, hydration, and treatment adherence. This randomized, prospective, single blind trial in Mexico will evaluate photobiomodulation (PBM) versus a conventional bioadhesive gel for prevention and treatment of antineoplastic therapy-induced OM in children aged 4-17 with leukemia, lymphoma, or head and neck tumors. A total of 49 participants will be enrolled. The study has two components: (1) Treatment - parallel comparison of PBM versus bioadhesive gel for established OM; (2) Prevention - crossover design in which patients receive both interventions across successive chemotherapy cycles. PBM will be delivered with a 660 nm device, 40 mW, 10 J/cm². The primary outcome is OM grade by the WHO scale assessed on days 7, 11, 14, and 21. Expected results include reduced OM incidence, severity, duration, and pain with favorable safety and tolerability, supporting standardized PBM protocols in pediatric oncology in Mexico.
Detailed description
Oral mucositis is a common and debilitating adverse effect in pediatric patients undergoing cancer treatment. It significantly affects quality of life, nutrition, hydration, and treatment adherence. Photobiomodulation is a promising non-invasive therapy, but there is limited evidence in the pediatric population, particularly in Mexico. Objective: To evaluate the clinical utility of FBM in the prevention and treatment of OM induced by antineoplastic therapy in pediatric cancer patients, compared to conventional treatment with bioadhesive gel. This is a randomized, single-blind clinical trial in patients aged 4 to 17 years. The design includes two arms: 1) Treatment (parallel design: FBM vs. gel for established OM) and 2) Prevention (crossover design: patients receive both interventions in successive cycles of chemotherapy). The primary outcome will be the degree of OM according to the WHO scale. FBM is expected to significantly reduce the incidence, severity, and duration of OM, as well as the intensity of pain. In addition, scientific evidence will be generated on the implementation of FBM in pediatric oncology in Mexico, with the potential to standardize protocols that improve patients' quality of life and optimize the management of oral complications of antineoplastic treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Simple-blind randomized clinical trial. Two arms: Treatment (parallel design). Prevention (crossover design).
| Arm | Type | Receives |
|---|---|---|
| Prevention arm | Experimental | Device: Photobiomodulation, Drug: bioadhesive gelCross-over design: patients receive both interventions (photobiomodulation in the first phase and are reassigned to receive bioadhesive gel in the second phase), i.e., in successive cycles of chemotherapy, within the first three days of the start of chemotherapy, in the absence of oral mucositis. |
| Treatment | Experimental | Device: Photobiomodulation, Drug: bioadhesive gelTreatment arm: randomization into two groups: one receives photobiomodulation, and the other receives bioadhesive gel, in the presence of oral mucositis. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationFor the prevention arm, photobiomodulation will be applied three alternate days per week starting on the first three days of chemotherapy. It will be applied to areas such as the corners of the mouth, the lip mucosa, the buccal mucosa, the lateral edges of the tongue, the ventral tongue, the anterior floor of the mouth, and the soft palate. For the treatment arm, photobiomodulation will be applied every other day of the week from the detection of oral mucositis until resolution. The application sites will be the affected mucosal areas, whether they present erythema or ulcerations. | Device | Prevention arm, Treatment |
| bioadhesive gelApplication of bioadherent gel Rinse with bioadherent gel, 5 consecutive days, 30 to 60 minutes before each meal. Or apply with a swab in young children who are unable to rinse. | Drug | Prevention arm, Treatment |
Primary outcome
Oral mucositis grade
Time frame: Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)
Grade of oral mucositis assessed using the World Health Organization (WHO) oral mucositis scale (0-4). Assessments performed by a blinded clinician trained in the scale
2 secondary outcomes
Incidence of oral mucositis
Time frame: Per chemotherapy cycle and overall study period (up to 21 days post intervention).
Oral mucositis Duration outcome
Time frame: Mesured for each episode during follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María C Palacios, PhD study director
Universidad de Guanajuato
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and bioadhesive gel in people with Oral Mucositis and Chemotherapy Effect, run by Universidad de Guanajuato.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana P Rodríguez, MSc (+52 4737387357, mp.rodriguezvargas@ugto.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis grade (time frame: Days 7, 11, 14, and 21 after intervention initiation for each episode/cycle (each cycle is 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.