Photobiomodulation Alone Versus Photobiomodulation Combined With Topical Oral Oxygen Therapy for Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Clinical Trial

Brief summary (registry, in English)

Oral mucositis is the inflammation and ulceration of the mucous membranes within the oral cavity, characterized by atrophy, edema, and erythema (1), and it occurs in nearly all patients with advanced head and neck cancer (HNC) receiving chemotherapy and radiotherapy \[2,3\]. It can seriously disrupt a person's life, affecting both quality of life and the course of treatment (2). Identifying the optimal management for oral mucositis remains a significant clinical challenge. Therapeutic modalities such as photobiomodulation (PBM) and benzydamine have shown beneficial effects in reducing mucosal injury and accelerating healing (3). In addition, maintaining proper oral hygiene and using adjunctive therapeutic agents can help minimize mucositis severity. Advanced interventions, including low-level laser therapy and optimized radiation delivery techniques like Intensity-Modulated Radiotherapy, may further reduce the incidence and severity of oral mucosal damage (4). PBM can improve tissue regeneration, promote wound healing, and minimize pain and inflammation (5). Patients unable to take non-steroidal anti-inflammatory drugs can benefit from it in addition to enhancing tissue regeneration and post-surgery recovery (6). Oxygen plays a fundamental role in wound healing, as it is required for cellular energy production, protein synthesis, cell proliferation, angiogenesis, and tissue repair. Oxygen tension varies by anatomical location, and wound sites often remain relatively hypoxic, which increases the risk of infection and ultimately delays or impairs tissue regeneration (7). Consequently, therapeutic strategies aimed at enhancing oxygen availability within the wound environment have been shown to promote more effective wound management and accelerated healing outcomes(8).

What you commit to

• Study type: Interventional · Phase 1/2
• Planned participants: 46
• From Aug 2026 to the primary completion date, Sept 2026
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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