Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients
Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy
1 other identifier
interventional
85
1 country
12
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedStudy Start
First participant enrolled
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2024
CompletedAugust 21, 2024
August 1, 2024
1.9 years
May 28, 2019
August 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IThe primary effectiveness endpoint is the severity of oral mucositis at week 6 of radiation treatment according to the Oral Mucositis Index (OMI) score.
The primary effectiveness endpoint of the study is the severity of oral mucositis as assessed by the Oral Mucositis Index (OMI) score, on a scale of 0-60.
approximately 6 weeks after patient begins radiation therapy
Secondary Outcomes (2)
World Health Organization (WHO) Oral Toxicity Scale at week 6
approximately 6 weeks after patient begins radiation therapy
Changes in overall quality of life over the 6-week treatment period
difference between baseline and (approximately) 6 weeks after patient begins radiation therapy
Study Arms (4)
Active Device Treatment Cohort - Chemoradiation therapy
ACTIVE COMPARATORThe MuReva Phototherapy System consists of Light Control Unit and two Mouthpiece Cable Assemblies. 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 set.
Sham Device Treatment Cohort- Chemoradiation therapy
SHAM COMPARATORThe MuReva Phototherapy System (or sham control) is a Light Control Unit and a set of Mouthpiece Cable Assemblies. The sham control Mouthpiece Cable Assemblies 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 set.
Active Device Treatment Cohort - Radiation therapy only
ACTIVE COMPARATORThe MuReva Phototherapy System consists of Light Control Unit and two Mouthpiece Cable Assemblies. 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 set.
Sham Device Treatment Cohort- Radiation therapy only
SHAM COMPARATORThe MuReva Phototherapy System (or sham control) is a Light Control Unit and a set of Mouthpiece Cable Assemblies. The sham control Mouthpiece Cable Assemblies 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 set.
Interventions
Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
Standard oral care, oral hygiene and oral pain protocols
Eligibility Criteria
You may qualify if:
- 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 50 Gy to at least two oral cavity sites (i.e. buccal mucosa, floor of mouth, ventral tongue, lateral tongue, dorsal tongue, hard palate, and soft palate).
- If the subject is receiving concurrent chemotherapy, the treatment plan includes 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 ≤ 2.
- 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.
You may not qualify if:
- 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 RT.
- 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 dental prostheses or implants.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
The Oncology Institute
Long Beach, California, 90805, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
University of Mississippi Medical Center
Jackson, Mississippi, 29216, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
NYU Langone
New York, New York, 10016, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
MetroHealth
Cleveland, Ohio, 44109, United States
James Cancer Hospital at The Ohio State University
Columbus, Ohio, 43210, United States
Oklahoma Cancer Specialtists and Research Intstitute
Tulsa, Oklahoma, 74146, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The sponsor, clinical research organization (CRO), subjects, research staff and Investigators performing the weekly OM evaluations for the study will be blinded to the treatment assignments. Subjects will be mandated to use light-blocking eyewear. Only the research staff delivering treatment will be unblinded. No other personnel or visitors will be allowed in the treatment room during active/sham treatment. The Investigators will not administer the daily treatment and will not visit or observe the patient during device use in order to remain blinded. The Investigators will also remain blinded to the patients' responses to the weekly Self-Assessments.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2019
First Posted
June 3, 2019
Study Start
August 5, 2022
Primary Completion
June 26, 2024
Study Completion
July 18, 2024
Last Updated
August 21, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- December 2024 anticipated
- Access Criteria
- not yet determined
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify individual subjects. At most, the Web site will include a summary of the results after the study is completed. You can search this Web site at any time. If the results of this study are published, individual subject identity will remain confidential. Data, salivary fluid specimens and photographs collected in this research might be de-identified (name and any identifying information will be removed) and used for future research or distributed to another investigator for future research.