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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 20, 2020
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 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
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 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 5 minutes. Light therapy parameters for the MuReva Phototherapy System will be as follows for all subjects receiving active light therapy: mouthpiece 660nm, 2-8 J/cm2, irradiance < 75mW/cm2. Subjects who stay on CRT treatment past 6 weeks will continue to receive treatment with their assigned device up through 8 total weeks of treatment (for a maximum total of 40 device 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) an anticipated 30 to 40 times during the treatment period (i.e., 5 days during each of the 6-8 CRT treatment weeks) and for one 2-week post RT follow-up visit. Weekly, subjects will be evaluated for QOL, pain, OM and for device safety. At the conclusion of the final CRT session and evaluation, each subject will complete a user validation survey. There will be one 2-week post RT follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 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 Concurrent Radiation and Chemotherapy
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 1, 2021

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 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
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 Name: Pain medication, oral rinses




Primary Outcome Measures :
  1. Incidence of severe oral mucositis (WHO grade 3 and 4) at week 6 of chemoradiation therapy. [ Time Frame: 6-8 weeks of photobiomodulation and chemoradiation therapy ]
    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 :
  1. Oral Mucositis (OM) Grade and Incidence, [ Time Frame: 6-8 weeks, evaluated once per week ]
    Radiation therapy oncology group scale (RTOG) 0 (Normal)- 4 (necrosis/hemorrhage), 5= death

  2. Oral Mucositis (OM) Grade and Incidence, [ Time Frame: 6-8 weeks, evaluated once per week ]
    World Health Organization scale (WHO) 0 (Normal)- 4 (oral alimentation not possible), 5= death

  3. Analgesic Usage [ Time Frame: 6-8 weeks, evaluated daily ]
    World Health Organization (WHO) analgesic ladder Steps 1-3: 1= non opioid, 2= weak opioid, 3= strong opioid



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 at least one oral site (buccal mucosa, floor of mouth, ventral/lateral tongue, soft palate, oropharynx);
  4. 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 AND/OR paclitaxel administered in a standard weekly (30-45mg/m2) regimen in combination with carboplatin administered in standard weekly (1.0-2.0 AUC) 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;
  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. Subject demonstrates capability in sustaining mouthpiece in oral cavity for recommended time during Screening procedure
  10. Subject demonstrates willingness to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  1. Subject is currently receiving, or has previously received chemotherapy or chemoradiotherapy within the past 2 years;
  2. Subject has previously been diagnosed with another type/site of cancer that has not been controlled or has been active in the past 2 years.
  3. Subject is pregnant or nursing;
  4. Subject is receiving medications indicated for the treatment and/or prevention of mucositis (e.g., palifermin);
  5. Subject has had prior radiation to the head and neck;
  6. Subject has a diagnosis that is prone to affect wound healing, e.g., uncontrolled diabetes;
  7. Subject has trismus with an interincisal distance of 30mm or less
  8. Subject has an active infection in the oropharynx or oral cavity;
  9. Subject has a salivary disturbance, e.g., Sjögren's syndrome;
  10. Subject has any grade of oral mucositis (per WHO Oral Toxicity Scale);
  11. Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol;
  12. Subject has a visual analog pain scale (VAS) score of 5 or greater localized to the oral cavity but is NOT tumor related.
  13. Subject is unable to participate in the study because of a concurrent disease state that, in the opinion of the Principal Investigator, would affect the study endpoints, e.g., dental disease or COVID19 (SARS-CoV-2 infection active or recovered).
  14. Subject is currently using, and/or has used in the last 30 days, any tobacco or nicotine products, with the exception of nicotine patches.
  15. Subject is currently taking, or has taken in the last month, any marijuana (Cannabis sativa or Cannabis indica), or illicit drugs.
  16. Subject has 8 or more crowns OR subject is not considered eligible at the discretion of the oral maxillofacial dentist/surgeon.

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@lumitex.com
Contact: Michael Marotta, MS 440-801-1540 ext 215 mmarotta@imarcresearch.com

Locations
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United States, Kentucky
St. Elizabeth Healthcare Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Prathish Shah, MD    859-301-2238    pratish.shah@stelizabeth.com   
Contact: Amy Pajk    859-301-4735    amy.pajk@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: James Zemer    716-898-6344    jzemer@ecmc.edu   
NYU Langone Recruiting
New York, New York, United States, 10016
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   
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: 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 Recruiting
Columbus, Ohio, United States, 43210
Contact: Meade C VanPutten, DDS    614-292-2994    meade.vanputten@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 20, 2020
Last Verified: August 2020
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: July 1, 2021 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
Infection
Gingivitis
Gingival Diseases
Periodontal Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs