Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients
Study Details
Study Description
Brief Summary
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 incidence of severe oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving concurrent radiation and chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study Design: A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.
Protocol-eligible subjects will be randomized in a 2:1 allocation to receive either the active MuReva Phototherapy System or sham control. Both the subjects and clinician evaluating the patients will be blinded to the treatment assignments. The sham device will be placed in the patient's mouth and operated in the same manner as the active device, but not deliver any therapy.
Subjects will begin device treatment sessions on the first day of chemoradiotherapy (CRT) treatment immediately prior to radiation treatment (RT) and will continue to receive once daily treatments prior to RT with their assigned device for 5 days per week for the duration of their CRT treatment (approximately 6 to 8 weeks, for a total of 30 to 40 device sessions depending on the standard of care regimen for the type of cancer). Each device treatment session will last approximately 10 minutes in total. Light therapy parameters for the MuReva
Phototherapy System will be as follows for all subjects receiving active light therapy:
mouthpiece 660nm, 2-10 J/cm2 nominal fluence. Subjects who stay on CRT treatment past 6 weeks will continue to receive treatment with their assigned devices up through 8 total weeks of treatment (for a maximum total of 40 phototherapy sessions). In addition, all subjects, regardless of randomization, will be kept on standard oral care, oral hygiene and oral pain protocols.
All subjects will visit the study site once during the Screening period (Days -28 to 1) and an anticipated 30 to 40 times during the treatment period (i.e., 5 days during each of the 6-8 CRT treatment weeks). Weekly, subjects will be evaluated for oral mucositis and for device safety. The weekly assessments will continue through the final RT session. A post-therapy assessment will be done approximately 2 weeks after completion of RT. At the conclusion of this assessment each subject's participation in the study will be complete.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Device Treatment Cohort The MuReva Phototherapy System consists of Light Control Unit and a Mouthpiece Cable Assembly. Subjects will begin device treatment photobiomodulation sessions on the first day of radiotherapy (RT) treatment. They will receive once-daily investigative device photobiomodulation treatments prior to radiation therapy (RT) with their assigned Mouthpiece for 5 days per week for the duration of their CRT treatment. Each device treatment session will last up to 5 minutes, not including up to 5 additional minutes for treatment breaks. All subjects will visit the study site once during the Screening period (Days -28 to 1) and an anticipated 30 to 40 times during the treatment period. Each patient will be assigned their own Mouthpiece Cable Assembly. |
Device: Photobiomodulation
Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
Other Names:
Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Names:
|
| Sham Comparator: Sham Device Treatment Cohort The MuReva Phototherapy System (or sham control) is a Light Control Unit and a Mouthpiece Cable Assembly. The sham control Mouthpiece Cable Assembly will appear identical to the active Mouthpiece Cable Assembly, and will be used in the same manner as the active cohort. However, the sham control device will be configured where the mouthpiece will not emit any light at any time during the study. The same Light Control Unit will be used with sham and active Mouthpiece Cable Assemblies. Each patient will be assigned their own Mouthpiece Cable Assembly. |
Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of severe oral mucositis (WHO grade 3 and 4) at week 6 of chemoradiation therapy. [6-8 weeks of photobiomodulation and chemoradiation therapy, evaluated weely]
The primary effectiveness endpoint of the study is 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.
Secondary Outcome Measures
- Analgesic Usage [6-8 weeks, evaluated daily]
World Health Organization (WHO) analgesic ladder Steps 1-3: 1= non opioid, 2= weak opioid, 3= strong opioid
- Changes in overall quality of life over the 6-week treatment period [6-8 weeks, evaluated weekly]
Oral Mucositis Weekly Questionnaire-Head and Neck Cancer
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has been diagnosed with pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil or base of tongue.
-
Within 28 days of Screening, subject is scheduled to receive a continuous course of Intensity-Modulated Radiation Therapy (IMRT) over an estimated 6 to 8 weeks (treatment week is defined as 5 fractions per week). The initial target volume encompassing the gross and subclinical disease sites will receive 5 fractions per week with a minimum cumulative dose of 50 Gray (Gy) for low to intermediate risk (sites of suspected subclinical spread) and maximum cumulative dose of 70 Gy for gross tumor volume/High risk (Primary tumor and involved lymph nodes).
-
The subject's planned radiation treatment fields include a minimum of 30 Gy to at least one oral cavity site (buccal mucosa, floor of mouth, ventral/lateral tongue, hard and soft palate).
-
The subject's treatment plan includes chemotherapy with Cisplatin administered in either a standard weekly (30-40 mg/m2) or approximately every 21 days (80-100mg/m2) regimen OR Carboplatin administered in standard weekly (1.0-2.0 AUC) regimen WITH/WITHOUT Paclitaxel administered in a standard weekly (30-45mg/m2) regimen.
-
Subject is at least 22 years of age.
-
Subject has no dental or oral health conditions that would preclude daily use of a mouthpiece and demonstrates capability in sustaining mouthpiece in oral cavity for recommended time during Screening procedure.
-
Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤
-
Subject is able to read and understand the Informed Consent Form (ICF) and has voluntarily provided written informed consent.
-
For the entire duration of their treatment, the subject will not use any tobacco or nicotine products with the exception of nicotine patches.
-
For the entire duration of their treatment, the subject will not use any inhaled cannabis products or any illicit drugs.
Exclusion Criteria:
-
Subject is currently receiving or has previously received chemotherapy or chemoradiotherapy within the past 2 years and the oral cavity has not yet fully recovered.
-
Subject is given neo-adjuvant or induction chemotherapy for Head and Neck cancer prior to starting combined CRT.
-
Subject has been diagnosed with another type/site of cancer that has not been controlled.
-
Subject is pregnant or nursing.
-
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 a diagnosis that is prone to affect wound healing, e.g., uncontrolled diabetes.
-
Subject has trismus with an interincisal distance of 30mm or less.
-
Subject has an active infection in the oropharynx and/or oral cavity (any infection in the oropharynx and/or oral cavity at the time of screening must be addressed prior to first radiation treatment).
-
Subject has a salivary disturbance, e.g., Sjögren's syndrome.
-
Subject has any grade of oral mucositis per WHO Oral Toxicity Scale.
-
Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol.
-
Subject has a Baseline mouth pain score of greater than 5 out of 10 on question 6 of the OMWQ-HN. Exception can be made if Principal Investigator determines the cause of mouth pain is due to tumor or surgery site pain.
-
Subject is unable to participate in the study because of a concurrent or recent disease state that, in the opinion of the Principal Investigator, would affect the study endpoints, e.g., dental disease or COVID-19 (active or recovered).
-
Subject has 8 or more fixed dental prostheses (such as crowns or bridges), implants or large dental amalgams.
-
Subject is not considered eligible at the discretion of the oral maxillofacial dentist/surgeon. Exception can be made if all items identified on the dental exam have been addressed prior to first radiation treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | St. Elizabeth Healthcare | Edgewood | Kentucky | United States | 41017 |
| 3 | Erie County Medical Center | Buffalo | New York | United States | 14215 |
| 4 | NYU Langone | New York | New York | United States | 10016 |
| 5 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
| 6 | MetroHealth | Cleveland | Ohio | United States | 44109 |
| 7 | James Cancer Hospital at The Ohio State University | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- MuReva Phototherapy Inc.
Investigators
- Study Director: Nancy B Lipko, MD MBA, MuReva Phototherapy Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LLD-001