Intraoral Photobiomodulation Device Safe, Reduces Oral Mucositis in HNC
An LED-based intraoral device for photobiomodulation therapy was safe and reduced severe oral mucositis in patients with head and neck cancers.
Oral mucositis was reduced significantly in patients receiving active photobiomodulation.
An LED-based intraoral device for photobiomodulation therapy appeared safe and significantly reduced instances of severe oral mucositis vs a placebo procedure for patients with head and neck cancers receiving radiotherapy, according to data from a trial (NCT03972527) presented at the 2025 ASTRO Annual Meeting.1
Patients receiving active photobiomodulation therapy experienced 70% (P = .042) and 36% (P = .046) relative reductions in severe oral mucositis at 2 weeks post treatment and 6 weeks of radiotherapy, respectively, compared with placebo.
At 6 weeks of radiotherapy, 36.8% of the active arm had grade 3 or 4 oral mucositis vs 57.1% in the placebo arm. Likewise, 10.8% of the active arm had grade 3/4 oral mucositis 2 weeks after radiotherapy vs 36.4% in the placebo arm.
Additionally, patient-reported outcomes reflected that participants who received photobiomodulation therapy experienced significantly less increased mouth and throat soreness, with a score of 1.5/5 in the arm receiving photobiomodulation therapy and 2.2 in the group receiving the placebo (P = .029).
Throat pain was also reduced in the active arm, with a score of 3.8 out of 10 compared with 5.3 in the placebo arm (P = .028). Scores for mouth and throat soreness and throat pain were taken from the validated patient-reported outcome tool Oral Mucositis Weekly Questionnaire.
Patients beginning cancer treatment without previous placement of a percutaneous endoscopic gastrostomy (PEG) feeding tube saw a 59% reduction in PEG placements; 15.2% of patients in the active arm has PEG placements vs 37% in the placebo arm (P = .073).
No device-related adverse events were found in patients receiving active photobiomodulation therapy, and 2574 out of 2619 sessions (98.3%) were completed in full.
What Patients Were Eligible for Photobiomodulation Therapy and How Much Did They Receive?
The prospective, double-blind, sham-controlled trial, which was randomized 1:1, took place across 12 cancer centers, with 85 participants completing the trial. Patients underwent a continuous course of intensity-modulated radiation therapy (IMRT) for 6 to 8 weeks, including some patients who received concurrent chemotherapy.
Patients were eligible if they received more than 50 Gy of radiation in at least 2 oral cavity sites, with a maximum cumulative 70 Gy of radiation. Patients were allowed to use pain medications and oral mouthwashes.
Participants received daily 10-minute photobiomodulation therapy at 660 nm, 6 J/cm2 for 10 minutes immediately before radiation therapy along with daily and weekly assessments. Investigators followed up with patients 2 weeks after treatment concluded. Patients received 30-40 device sessions, dependent on the standard of care regimen by cancer type.2
Those receiving the sham procedure had the placebo device placed in their mouth and operated as if it delivered photobiomodulation therapy without delivering active therapy. Regardless of assignment to the active or placebo arm, patients were kept on standard protocols for oral care, oral pain, and oral hygiene. Participants were required to wear light-blocking eyewear during active or placebo treatment.
The primary outcome measured was severity of oral mucositis at week 6 of radiation therapy measured with the Oral Mucositis Index, and secondary outcomes measured included World Health Organization Oral toxicity scale at week 6 and changes in overall quality of life over the 6-week treatment period
Why Use Photobiomodulation Therapy?
As researchers outlined in the study’s abstract, the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) recommend photobiomodulation (PBM) therapy as an option to reduce or prevent mucositis in patients undergoing radiotherapy for head and neck cancers.1
Photobiomodulation can promote wound healing by using non-ionizing light in the visible and near-infrared light spectra to alter biological systems.
References
- Hu KS, Shah PH, Nguyen MC, et al. Safety and efficacy of an LED-based intraoral device for daily photobiomodulation therapy prior to cancer treatment for reducing severity of oral mucositis in head and neck cancer patients. Presented at: ASTRO’s 67th Annual Meeting. September 27-October 1, 2025; San Francisco, California. Abstract 1006.
- Photobiomodulation to demonstrate safety and reduce the incidence of oral mucositis in adult head & neck cancer patients. ClinicalTrials.Gov. June 3, 2019. Updated August 21, 2024. Accessed September 29, 2025. https://clinicaltrials.gov/study/NCT03972527
