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 |
|---|---|---|
St. Elizabeth Healthcare, Edgewood, KY | 1 Medical Village Dr, Edgewood, KY 41017, USA | |
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 | |
The Christ Hospital, Cincinnati, OH | 2139 Auburn Ave, Cincinnati, OH 45219, USA | |
MetroHealth, Cleveland, OH | 2500 Metrohealth Dr, Cleveland, OH 44109, USA | |
James Cancer Hospital at The Ohio State University | 460 W 10th Ave, Columbus, OH 43210, USA | |
University of Alabama at Birmingham | 1700 6th Ave S, Birmingham, AL 35233, USA |
Study Sites
St. Elizabeth Healthcare, Edgewood, Kentucky
Status: Enrolling
Contact: Prathish Shah, MD 859-301-2238 pratish.shah@stelizabeth.com
Contact: Amy Pajk 859-301-4735 amy.pajk@stelizabeth.com
Erie County Medical Center, Buffalo, New York
Status: Enrolling
Contact: Jennifer L Frustino, DDS PhD 716-898-1461 jfrustino@ecmc.edu
Contact: James Zemer 716-898-634 jzemer@ecmc.edu
NYU Langone, New York, New York
Status: Enrolling
Contact: Kenneth Hu, MD 212-731-5003 Kenneth.Hu@nyulangone.org
Contact: Rebecca Mota de Vasconcelos, DDS,PhD 646-501-6727 Rebeca.MotaVasconcelos@nyulangone.org
The Christ Hospital, Cincinnati, Ohio
Status: Enrolling
Contact: Cornelia McCluskey, MD 513-321-4333 Cornelia.Mccluskey@thechristhospital.com
Contact: Lisa Woeste, RN 513-321-4333 Lisa.woeste@thechristhospital.com
MetroHealth, Cleveland, Ohio
Status: Enrolling
Contact: Ashley Sekhon, MD 216-778-8299 asekhon@metrohealth.org
Contact: Jodi Bell, MA 216-778-3867 jbell3@metrohealth.org
James Cancer Hospital at The Ohio State University, Columbus, Ohio
Status: Enrolling
Contact: Meade C VanPutten, DDS 614-292-2994 meade.vanputten@osumc.edu
Contact: Betina McNeil 614-293-8574 Betina.McNeil@osumc.edu
University of Alabama at Birmingham, Birmingham, Alabama
Status: Enrolling
Contact: Hillary Avery 205-975-2880 hilaryavery@uabmc.edu
Principal Investigator: Christopher Willey, MD