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

Condition(s) studied

Investigational drug(s) / intervention(s)

sirolase xtent laser: SIROLaser Xtend specification Laser type :Diode laser Wavelength:970 nm ± 15 nm Optical power (CW): SIROLaser Xtend: approx. 0.5-5.0 W Peak-pulse: 23 µs fixed 3 sessions a week (MASCC-aligned parameters, e.g., 970 nm, \~40 mW, 2-4 J/cm² per point) from the first RT session (baseline) until the

blue m gel: Aqua, Alcohol, Glycerin, Silica, Sodium Saccharin, Sodium Perborate, Citric Acid, PEG-32, Sodium Gluconate, Lactoferrin, Xanthan Gum, Cellulose Gum

Study summary

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).

Eligibility

Primary outcome measure(s)

• Incidence of WHO grade — Assessments are done at Session 4, Session 7, Session 14, Session 21 and Session 30, which correspond to Day 4, Day 8, Day 17, Day 25 and Day 38.Cycle length is not applicable because this trial uses sessions, not treatment cycles.
  The severity of OM was assessed using the WHO Oral Toxicity Scale, scored on a 4-grade scale (1, soreness ± erythema; 2, erythema and ulcer, but patient can swallow solid foods; 3, ulcers with extensive erythema and the patient can not swallow food; and 4, mucositis to the extent that alimentation is not possible).

Trial sites (1)

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