Clinical trial · Interventional
Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
Comparison of Two Photobiomodulation Protocols for the Oral Mucositis and Xerostomia Prevention in Irradiated Head and Neck Cancer Patients: a Randomized, Multicenter, Single-blind Controlled 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)
Head and neck cancer (HNC) are among the most frequent malignancies in the world. The main treatment modalities for HNC are surgical excision, radiotherapy (RT), and chemotherapy (CT). Severe oral sequelae such as oral mucositis (OM), dysgeusia, opportunistic infections, trismus, and xerostomia/hyposalivation can affect HNC patients due to oncological treatment with RT and QT. Photobiomodulation therapy (PBMT) with an intraoral low-power laser has been studied as an excellent tool in the management of OM and xerostomia and thus improves the tolerability of RT in the head and neck region. The aim of this multicenter, randomized, single-blind clinical trial is to compare the effects of two photobiomodulation protocols (intraoral application low-level laser and defocused extraoral application of high-power laser) in the management of oral mucositis (OM) and xerostomia in head and neck cancer patients undergoing radiotherapy (RT). It is expected defocused extraoral high-power photobiomodulation shows results as good as intraoral photobiomodulation on the management of oral mucositis.
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 |
|---|---|---|---|
| Hyposalivation | — | UNRESOLVED | — |
| Mucositis | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intraoral photobiomodulation protocol
- description
- Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Intraoral protocol will utilize a low-level laser device (MMOptics Ltda, Sao Carlos, Sao Paulo, Brazil) with wavelength 660nm, power 100 mW, spot 0.03 cm², dose 10 J/cm², and time 3 seconds. The irradiations will be punctual and in a contact form, with 1 cm between the points, perpendicular to the oral mucosa, avoiding the tumor site and will be performed: 6 points on the labial mucosa (3 in the upper and 3 in the lower), 2 points on the labial commissure (1 on the right and 1 on the left), 8 points on the jugal mucosa (4 on the right and 4 on the left), 8 points on the lateral border of the tongue (4 on the right and 4 on the left), 5 points on the ventral tongue (2 on the right, 2 on the left side and 1 point on the apex), 4 points on the oral floor (2 on the right and 2 on the left side).
- interventionNames
- Device: Photobiomodulation therapy
- type
- ACTIVE_COMPARATOR
- label
- Extraoral photobiomodulation protocol
- description
- Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Extraoral protocol will utilize a defocused high-level laser device (Gemini® Diode Laser - UltraDent) with wavelength 810 + 980 nm, power 1 W, spot 4.91 cm², dose 6.11 J/cm², and time 30 seconds. The irradiations will be punctual and in a contact form, perpendicular to the skin, avoiding the tumor site and will be performed: * 5 points on the face (2 on both right and left cheeks, 2 points on both right and left parotid gland region and 1 on the lip); * 5 points on the neck area (1 point on the sublingual gland region, 2 points on the right and left submandibular spaces and 2 points on the neck nearby lymphatic chain).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of cancer in the oral cavity and oropharynx any clinical stage based on TNM staging of head and neck cancer; * Patients who received oral care prior to oncological treatment; * Patients who will receive conformational radiotherapy (RT-C3D) or Intensity-modulated radiotherapy (IMRT) from 50 Gy to 70 Gy (primary radiation field) in daily doses of 1.8-2, 12 Gy divided five times per week (from Monday to Friday), totalizing 6 to 7 weeks of treatment. They may receive exclusive RT or with chemotherapy concomitant with cisplatin (100 mg/m2 every 21 days or 50 mg/m2 per week); * Patients feeding orally or by parenteral nutrition; * Patients who agree to participate in the study after reading, filling, and signing the Consent Form for Participation in Clinical Research. Exclusion Criteria: * Patients who develop head and neck radiodermatitis and for this reason interrupt the survey; * Patients who do not appear in four or more PBMT or RT sessions.
References
Publications (1)
- DERIVEDKlein IP, Pinto MBR, So BB, de Farias Gabriel A, Mendonca NF, da Cruz Santos LB, Farias KM, Mores AL, Martins MAT, Silva ACPRE, Brandao TB, Santos-Silva AR, Alves FA, Martins MD. Intraoral vs. extraoral photobiomodulation therapy for oral mucositis in head and neck cancer patients: a multicenter, randomized, single-blind clinical trial. Support Care Cancer. 2025 Sep 10;33(10):842. doi: 10.1007/s00520-025-09877-w. PMID 40928526