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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972527
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
MuReva Phototherapy Inc.

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.

Condition or disease Intervention/treatment Phase
Oral Mucositis (Ulcerative) Oral Mucositis (Ulcerative) Due to Radiation Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy Head and Neck Cancer Device: Photobiomodulation Other: Routine Oral Care and Analgesia Not Applicable

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 1:1 allocation to receive either the active MuReva Phototherapy System or a 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 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 RT 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: 660nm, 2-12 J/cm2 nominal fluence. Subjects who stay on RT 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 RT 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : August 5, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2024

Arm Intervention/treatment
Active Comparator: Active Device Treatment Cohort - Chemoradiation therapy
The 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.
Device: Photobiomodulation
Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
Other Name: low-level laser therapy

Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Name: Pain medication, oral rinses

Sham Comparator: Sham Device Treatment Cohort- Chemoradiation therapy
The 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.
Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Name: Pain medication, oral rinses

Active Comparator: Active Device Treatment Cohort - Radiation therapy only
The 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.
Device: Photobiomodulation
Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
Other Name: low-level laser therapy

Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Name: Pain medication, oral rinses

Sham Comparator: Sham Device Treatment Cohort- Radiation therapy only
The 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.
Other: Routine Oral Care and Analgesia
Standard oral care, oral hygiene and oral pain protocols
Other Name: Pain medication, oral rinses




Primary Outcome Measures :
  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. [ Time Frame: approximately 6 weeks after patient begins radiation therapy ]
    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.


Secondary Outcome Measures :
  1. World Health Organization (WHO) Oral Toxicity Scale at week 6 [ Time Frame: approximately 6 weeks after patient begins radiation therapy ]
    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.

  2. Changes in overall quality of life over the 6-week treatment period [ Time Frame: difference between baseline and (approximately) 6 weeks after patient begins radiation therapy ]
    Oral Mucositis Weekly Questionnaire-Head and Neck Cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Subject has been diagnosed with pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil or base of tongue.
  2. 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).
  3. 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).
  4. 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.
  5. Subject is at least 22 years of age.
  6. 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.
  7. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  8. Subject is able to read and understand the Informed Consent Form (ICF) and has voluntarily provided written informed consent.
  9. For the entire duration of their treatment, the subject will not use any tobacco or nicotine products with the exception of nicotine patches.
  10. For the entire duration of their treatment, the subject will not use any inhaled cannabis products or any illicit drugs.

EXCLUSION CRITERIA

  1. 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.
  2. Subject is given neo-adjuvant or induction chemotherapy for Head and Neck cancer prior to starting RT.
  3. Subject has been diagnosed with another type/site of cancer that has not been controlled.
  4. Subject is pregnant or nursing.
  5. Subject is receiving medications indicated for the treatment and/or prevention of mucositis (e.g., palifermin).
  6. Subject has had prior radiation to the head and neck.
  7. Subject has a diagnosis that is prone to affect wound healing, e.g., uncontrolled diabetes.
  8. Subject has trismus with an interincisal distance of 30mm or less.
  9. 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).
  10. Subject has a salivary disturbance, e.g., Sjögren's syndrome.
  11. Subject has any grade of oral mucositis per WHO Oral Toxicity Scale.
  12. Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol.
  13. 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.
  14. 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).
  15. Subject has 8 or more dental prostheses or implants.
  16. 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.
  17. Subject is receiving any medications with oral photoprotection indications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972527


Contacts
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Contact: Vedang Kothari, BSE 440-243-8401 VKothari@murevapt.com
Contact: Michael Marotta, MS 216-513-0932 MMarotta@murevapt.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Hillary Avery    205-975-2880    hilaryavery@uabmc.edu   
Contact    205-934-5670      
Principal Investigator: Christophem Wiley, MD         
United States, Kentucky
St. Elizabeth Healthcare Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Prathish Shah, MD    859-301-2238    pratish.shah@stelizabeth.com   
Contact: Lauren Willett    859-301-4735    Lauren.Willett@stelizabeth.com   
United States, New York
Erie County Medical Center Recruiting
Buffalo, New York, United States, 14215
Contact: Jennifer L Frustino, DDS PhD    716-898-1461    jfrustino@ecmc.edu   
Contact: Daniel Leon    716-898-6344    dleon@ecmc.edu   
NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Kenneth Hu, MD    212-731-5003    Kenneth.Hu@nyulangone.org   
Contact: Marlene Feron-Rigodon    646-501-6727    Marlene.Feron-Rigodon@nyulangone.org   
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Cornelia McCluskey, MD    513-321-4333    Cornelia.Mccluskey@thechristhospital.com   
Contact: Lisa Woeste, RN    513-321-4333    Lisa.woeste@thechristhospital.com   
MetroHealth Recruiting
Cleveland, Ohio, United States, 44109
Contact: David Ludlow, MD    216-778-8299    dludlow@metrohealth.org   
Contact: Koretia Williams    216-778-3867    kwilliams7@metrohealth.org   
James Cancer Hospital at The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sachin Jhawar, MD    614-292-2994    jhawar.5@osumc.edu   
Contact: Betina McNeil    614-293-8574    Betina.McNeil@osumc.edu   
Sponsors and Collaborators
MuReva Phototherapy Inc.
Investigators
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Study Director: Nancy B Lipko, MD MBA MuReva Phototherapy Inc.
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Responsible Party: MuReva Phototherapy Inc.
ClinicalTrials.gov Identifier: NCT03972527    
Other Study ID Numbers: LLD-001
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: March 2023 anticipated
Access Criteria: not yet determined

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MuReva Phototherapy Inc.:
photobiomodulation
LLLT (low-level laser therapy)
low-level laser therapy
oral mucositis
wound healing
radiation therapy
chemotherapy
antineoplastic therapy
side effects
phototherapy
low-level light therapy
Additional relevant MeSH terms:
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Gingivitis, Necrotizing Ulcerative
Head and Neck Neoplasms
Mucositis
Stomatitis
Ulcer
Neoplasms by Site
Neoplasms
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Fusobacterium Infections
Fusobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Gingivitis
Gingival Diseases
Periodontal Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs