Our Clinical Study

Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

Trial Overview

The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the severity of oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving radiation therapy with or without concurrent chemotherapy.

Inclusion/Exclusion Criteria and Study Outcomes

Key Inclusion Criteria

Subject has been diagnosed with pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil or base of tongue.
Subject is scheduled to receive a continuous course of Intensity-Modulated Radiation Therapy (IMRT) within 28 days of screening over an estimated 6 to 8 weeks;
The subject’s planned radiation treatment fields include at least one oral site;
Subject is at least 22 years of age.

Key Exclusion Criteria

Subject is currently receiving, or has previously received chemotherapy or chemoradiotherapy within the past 2 years;
Subject has previously been diagnosed with another type/site of cancer in the past 2 years which has not been controlled or has been active.
Subject is receiving medications indicated for the treatment and/or prevention of mucositis (e.g., palifermin);
Subject has had prior radiation to the head and neck;
Subject has an active infection in the oropharynx or oral cavity;
Subject has any grade of oral mucositis (per WHO Oral Toxicity Scale)

Click here for additional inclusion and exclusion criteria.

Primary Outcome Measure

The primary effectiveness endpoint is the severity of oral mucositis at week 6 of treatment according to the Oral Mucositis Index (OMI) score.

Secondary Outcome Measures

The proportion of patients who have severe oral mucositis (Grade 3 or 4) at week 6 of treatment according to the World Health Organization (WHO) Oral Toxicity Scale.
Change in mouth pain over the 6-week treatment period.
Total number of days of analgesic (opioid) usage over the 6-week treatment period.
Retention of salivary flow over the 6-week treatment period.
Number of days patient cannot swallow over the 6-week treatment period.
Changes in overall quality of life over the 6-week treatment period.

Where to Participate

Title	Address	Description
Erie County Medical Center, Buffalo, NY	462 Grider St, Buffalo, NY 14215, USA
NYU Langone, New York, NY	339 E 38th St, New York, NY 10016, USA
St. Elizabeth Healthcare, Edgewood, KY	1 Medical Village Dr, Edgewood, KY 41017, USA
The Christ Hospital, Cincinnati, OH	2139 Auburn Ave, Cincinnati, OH 45219, USA
MetroHealth, Cleveland, OH	2500 Metrohealth Dr, Cleveland, OH 44109, USA
University of Alabama at Birmingham, Birmingham, AL	1700 6th Ave S, Birmingham, AL 35233, USA
University of Mississippi Medical Center, Jackson, MS	2500 N State St, Jackson, MS 39216, USA
Oklahoma Cancer Specialists and Research Institute, Tulsa, OK	12697 E 51st St, Tulsa, OK 74146, USA
Willis-Knighton Cancer Center, Shreveport, LA	2600 Kings Hwy, Shreveport, LA 71103, USA
The Oncology Institute, Long Beach, CA	2440 E South St, Long Beach, CA 90805, USA
Miami Cancer Institute, Miami, FL	8900 N Kendall Dr, Miami, FL 33176, USA
James Cancer Hospital at The Ohio State University, Columbus, OH	410 W 10th Ave, Columbus, OH 43210, USA