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Get in touch with us

Contact MuReva Phototherapy using this form.

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Address

8300 Dow Cir #500
Strongsville, OH
44136

Email

info@murevapt.com

Address

600 B Street
San Diego, CA
92101

Contact Us

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