MASCC 2025 Highlights: MuReva OM Dramatically Reduces Severe Oral Mucositis in HNC

MuReva OM, an innovative intra-oral photobiomodulation (PBM) device, is showing promise in reducing the burden of severe oral mucositis in patients undergoing radiation therapy for head and neck cancer. Presented by Dr. Alessandro Villa (United States) at MASCC 2025, new Phase III trial results highlight the device’s safety, excellent adherence, and significant clinical benefit—positioning MuReva OM as a potential standard of care in supportive oncology.

Oral mucositis (OM) is one of the most prevalent and debilitating toxicities associated with cancer treatment, particularly in patients receiving radiotherapy or chemoradiotherapy for head and neck cancer (HNC). Characterized by painful inflammation and ulceration of the oral mucosa, OM can significantly impair a patient’s ability to eat, speak, and maintain oral hygiene. In severe cases, it leads to treatment interruptions, nutritional deficits, opioid dependence, and hospitalizations, placing a substantial burden on both patients and healthcare systems. Despite the high incidence and clinical impact of OM, pharmacological interventions remain limited, and management is primarily supportive.

In recent years, photobiomodulation (PBM) therapy—also known as low-level laser therapy—has emerged as a promising non-pharmacologic approach to prevent and mitigate OM. PBM uses non-ionizing light in the visible to near-infrared spectrum to modulate cellular activity, promote tissue repair, and reduce inflammation. Recognizing its clinical utility, international supportive care guidelines (MASCC/ISOO and WALT) recommend PBM for OM prevention and treatment in patients undergoing cancer therapy. However, widespread adoption has been limited by the need for specialized equipment and operator expertise.

To address this gap, a novel intra-oral PBM device—MuReva OM—was developed to provide standardized, self-contained, operator-independent PBM treatment to the entire oral cavity. The device delivers red light at 660 nm wavelength, at a fluence of 6 J/cm², during a 10-minute daily session prior to radiation therapy.

Phase III trial (NCT03972527)

A multicenter, randomized, double-blind, placebo-controlled Phase III trial (NCT03972527) evaluated the safety and efficacy of MuReva OM in preventing severe OM in patients with HNC receiving definitive intensity-modulated radiation therapy (IMRT) over 6 to 8 weeks, with or without concurrent chemotherapy. The trial enrolled 85 participants across 12 U.S. cancer centers, all of whom had at least two oral cavity sites expected to receive >50 Gray (Gy), with a maximum cumulative radiation dose of 70 Gy.

Patients were randomized 1:1 to receive either the active MuReva OM device or a visually identical sham device. Treatments were administered daily immediately prior to scheduled radiation, and patients were monitored with daily and weekly OM assessments during radiotherapy and at a 2-week post-treatment follow-up.

Key Findings

The study demonstrated statistically and clinically significant reductions in severe OM (SOM) among patients receiving MuReva OM:

• During the course of radiation therapy, SOM incidence was reduced from 57.1% in the sham group to 36.8% in the active treatment group, representing a 36% relative reduction (p = 0.046).
• At 2 weeks post-treatment, the SOM incidence further declined to 10.8% in the active group compared to 36.4% in the sham group, corresponding to a 70% relative reduction (p = 0.042).
• The device was well tolerated, with no device-related adverse events reported.
• Adherence was excellent, with 98.3% of 2,619 total treatment sessions completed as planned using the full device.

Implications for Supportive Cancer Care

These findings highlight the clinical utility of MuReva OM as a non-invasive, patient-friendly solution to a major unmet need in cancer care. By reducing the burden of severe OM, the device may help maintain treatment intensity, reduce unplanned hospitalizations, and improve patient quality of life. The strong safety profile and ease of use further support its scalability and integration into routine radiotherapy workflows.

Given the high incidence of OM in patients with head and neck cancer, and the limited effectiveness of existing interventions, MuReva OM represents a meaningful advancement in supportive oncology care. It aligns with evidence-based guidelines and offers a practical, standardized approach to PBM delivery—potentially setting a new standard in OM prevention.

As cancer treatment becomes increasingly personalized, integrating supportive care innovations like MuReva OM will be essential to improving patient outcomes, adherence, and overall treatment experience across oncology settings.

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Written by Sona Karamyan, MD