Clinical trial · Interventional
Comparison of Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Oncology Patients
Comparison of Two Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Pediatric and Adolescent Oncology Patients: a Randomized, Controlled, Blinded Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Childhood cancers represent less than 1% of the malignant diseases diagnosed worldwide. Treatment modalities for childhood malignancies will differ depending on the diagnosis. The main treatments may include chemotherapy (QT), radiation therapy (RT), and surgery. The toxicity caused by QT and RT generates adverse effects in the mouth, among them oral mucositis (MO). MO is damage that occurs to the oral mucosa and these lesions are extremely painful, uncomfortable, and cause great morbidity for patients. The main treatment of MO is intraoral photobiomodulation therapy (TBMI), this therapy has been widely used, reducing the severity and pain of MO in patients. The use of extraoral photobiomodulation therapy (TFBME) has been employed in some recent studies and has shown efficacy for reducing and improving the severity of OM. The present study aims to compare the effect of two protocols of photobiomodulation therapy (TFBM) using intraoral and extraoral low power laser in the prevention and treatment of OM in pediatric oncology patients receiving treatment with high dose metrotexate (MTX-HD) and its chemotherapy combinations. Initially, 34 pediatric and adolescent oncology patients receiving intravenous (IV) QT from risk protocols will be selected. Participants will be allocated into 2 groups: Group I: TFBMI (n=17) and Group II: TFBME (n=17). The study will be conducted by a dental surgeon who will perform the initial assessment and reassessments (blinded to the groups) and another who will apply the TFBM. Patients will be evaluated daily from day 1 (D1 - beginning of the chemotherapy cycle) until D10 or until healing of the lesions. The evaluation will consist of oral mucosa examination for grading of OM, pain assessment, quality of life, oral health, depressionand saliva evaluation of patients to assess. The analyses will be performed in the PASW 18.0 program, initially the evaluation of the data distribution will be performed by applying the Shapiro-Wilk and Kolmogorov-Smirnov tests. If, after applying these tests, the data show a normal distribution (p\>0.05), the t-test will be used. If the distribution is non-normal after the application of the tests (p\<0.05), the Wilcoxon test will be used. The p value will be set at 5%. Logistic regression will be used in adjusted models to estimate the probability of occurrence of OM.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Childhood Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diode Semiconductor, Duo | Device | — | UNRESOLVED |
| Gemini laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intraoral photobiomodulation (PBMI)
- description
- Intraoral application: A low-power laser (Diode Semiconductor, Duo, MMOptics Ltda, São Carlos, SP, Brazil) with a wavelength of 660 nm (red). Four anatomical areas will be irradiated perpendicularly in oral mucosa through several anatomical points with a distance of 1 cm approximately between them in order to cover the largest area per cm² in each region. Application points: * Jugal mucosa: 4 points for each side: upper and lower internal buccal vestibule, (8 points). * Jugal mucosa for younger children 2 points internal buccal vestibule in the center - each side (4 points) * Tongue: 2 points on right and left lateral border and 1 point on right and left belly (6 points) * Oral floor: (2 points). * Upper and lower lips: 2 points on upper inner labial mucosa, 2 points on lower inner labial mucosa (4 points). * Soft palate: right and left sides (2 points)
- interventionNames
- Device: Diode Semiconductor, Duo
- type
- ACTIVE_COMPARATOR
- label
- Extraoral photobiomodulation (PBME)
- description
- A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm. The equipment will be programmed with 1 W of power. * 4 points - on each side of the face (2 on the right 2 on the left); * 2 points - on each side of the face: for younger children 1 point will be performed on each side of the face (1 on the right, 1 on the left) * 1 point on the lip; patients with sealed lips being able to cover both the upper and lower lip; * 5 points in the neck region (2 in right submandibular space and 2 in left submandibular space and submental space in the midline). * 3 points in the neck region for younger children (1 in right submandibular space and 1 in left submandibular space and submental space in the midline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of malignant neoplasia (hematological or solid tumors); * Responsible and participants agree to the study participation after reading and signing the Informed Consent Form (ICF) and Informed Term of Consent (TALE) for participation in Clinical Research; * They performed the chemotherapy infusions hospitalized in the pediatric oncology department of the 3rd east of HCPA; * Received the following chemotherapy protocols: MTX-HD, combination chemotherapy of MTX-HD, doxorubicin and cyclophosphamide; and MTX-HD and cyclophosphamide. Exclusion Criteria: * Participants will be excluded who: * Patients over the age of 18 years * Patients who will undergo HSCT
References
Publications (0)
Data not yet available