LED-Based Photobiomodulation Device Shows 70% Reduction in Severe Oral Mucositis for Head and Neck Cancer Patients
Key Insights
A randomized controlled trial across 12 cancer centers demonstrated that an LED-based intraoral photobiomodulation device (search) significantly reduced severe oral mucositis (search) in head and neck cancer (search) patients receiving radiotherapy.
Patients receiving active photobiomodulation therapy experienced a 70% relative reduction in severe oral mucositis (search) at 2 weeks post-treatment and 36% reduction at 6 weeks of radiotherapy compared to placebo.
The device showed excellent safety profile with no device-related adverse events and 98.3% session completion rate, while also reducing PEG feeding tube placements by 59%.
A novel LED-based intraoral photobiomodulation device (search) demonstrated significant efficacy in reducing severe oral mucositis (search) among head and neck cancer (search) patients undergoing radiotherapy, according to results from a prospective, double-blind, sham-controlled trial (NCT03972527) presented at the 2025 ASTRO Annual Meeting.
The randomized 1:1 trial, conducted across 12 cancer centers with 85 participants, showed that patients receiving active photobiomodulation therapy experienced a 70% relative reduction in severe oral mucositis (search) at 2 weeks post-treatment (P = .042) and a 36% reduction at 6 weeks of radiotherapy (P = .046) compared to placebo.
Clinical Outcomes and Safety Profile
At 6 weeks of radiotherapy, 36.8% of patients in the active treatment arm developed grade 3 or 4 oral mucositis (search) compared to 57.1% in the placebo group. The difference was even more pronounced at 2 weeks post-radiotherapy, with only 10.8% of the active arm experiencing grade 3/4 oral mucositis versus 36.4% in the placebo arm.
Patient-reported outcomes using the validated Oral Mucositis (search) Weekly Questionnaire revealed significant improvements in quality of life measures. Participants receiving photobiomodulation therapy reported substantially less mouth and throat soreness, scoring 1.5 out of 5 compared to 2.2 in the placebo group (P = .029). Throat pain scores were also reduced in the active arm at 3.8 out of 10 versus 5.3 in the placebo arm (P = .028).
The device demonstrated an excellent safety profile with no device-related adverse events reported. Treatment compliance was exceptional, with 2,574 out of 2,619 sessions (98.3%) completed in full.
Reduced Need for Feeding Tubes
Among patients who began cancer treatment without a percutaneous endoscopic gastrostomy (PEG) feeding tube, those receiving photobiomodulation therapy showed a 59% reduction in PEG placements. Only 15.2% of patients in the active arm required PEG placement compared to 37% in the placebo arm (P = .073).
Treatment Protocol and Patient Population
Eligible patients received more than 50 Gy of radiation in at least two oral cavity sites, with a maximum cumulative dose of 70 Gy. All participants underwent continuous intensity-modulated radiation therapy (IMRT) for 6 to 8 weeks, with some receiving concurrent chemotherapy.
The photobiomodulation therapy consisted of daily 10-minute sessions at 660 nm wavelength delivering 6 J/cm² immediately before radiation therapy. Patients received 30 to 40 device sessions depending on their standard of care regimen by cancer type. The sham control group received identical procedures with an inactive device.
The primary outcome measured severity of oral mucositis (search) at week 6 of radiation therapy using the Oral Mucositis Index, while secondary outcomes included the World Health Organization Oral Toxicity Scale at week 6 and changes in overall quality of life over the treatment period.
Clinical Significance and Guidelines
The Multinational Association of Supportive Care in Cancer (search)/International Society of Oral Oncology (search) (MASCC/ISOO (search)) currently recommend photobiomodulation therapy as an option to reduce or prevent mucositis in patients undergoing radiotherapy for head and neck cancers.
Photobiomodulation promotes wound healing by using non-ionizing light in the visible and near-infrared light spectra to alter biological systems, offering a non-pharmacological approach to managing this debilitating side effect of cancer treatment.