Oral Mucositis (Ulcerative)NCT03972527
Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients
A study testing Photobiomodulation and Routine Oral Care and Analgesia in people with Oral Mucositis (Ulcerative) and Oral Mucositis (Ulcerative) Due to Radiation, run by MuReva Phototherapy Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
- What is being tested?
- Photobiomodulation and Routine Oral Care and Analgesia
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Aug 2022to 18 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Subject is receiving any medications with oral photoprotection indications.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Erie County Medical Center
Buffalo, New York, 14215
The Christ Hospital
Cincinnati, Ohio, 45219
MetroHealth
Cleveland, Ohio, 44109
James Cancer Hospital at The Ohio State University
Columbus, Ohio, 43210
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017
University of Mississippi Medical Center
Jackson, Mississippi, 29216
The Oncology Institute
Long Beach, California, 90805
Miami Cancer Institute
Miami, Florida, 33176
NYU Langone
New York, New York, 10016
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Oklahoma Cancer Specialtists and Research Intstitute
Tulsa, Oklahoma, 74146
About this study
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
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.
Read the 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.
- Conditions
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Head and Neck Cancer
- Being tested
- Photobiomodulation, Routine Oral Care and Analgesia
- Keywords
- 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
- Medical subject headings
- Stomatitis, Ulcer, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called low-level laser therapy
Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
Routine Oral Care and AnalgesiaOther
Also called Pain medication, oral rinses
Standard oral care, oral hygiene and oral pain protocols
| Study group | Role | What they receive |
|---|---|---|
| Active Device Treatment Cohort - Chemoradiation therapy | Active comparator | 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. Receives: Device: Photobiomodulation; Other: Routine Oral Care and Analgesia |
| Sham Device Treatment Cohort- Chemoradiation therapy | Sham comparator | 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. Receives: Other: Routine Oral Care and Analgesia |
| Active Device Treatment Cohort - Radiation therapy only | Active comparator | 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. Receives: Device: Photobiomodulation; Other: Routine Oral Care and Analgesia |
| Sham Device Treatment Cohort- Radiation therapy only | Sham comparator | 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. Receives: Other: Routine Oral Care and Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 6 weeks after patient begins radiation therapy
Secondary outcomes (2)
World Health Organization (WHO) Oral Toxicity Scale at week 6
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.
Measured: approximately 6 weeks after patient begins radiation therapy
Changes in overall quality of life over the 6-week treatment period
Oral Mucositis Weekly Questionnaire-Head and Neck Cancer
Measured: difference between baseline and (approximately) 6 weeks after patient begins radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start5 Aug 2022
- Primary completion26 Jun 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis (Ulcerative)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- MuReva Phototherapy Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972527
- Sponsor's protocol ID
- LLD-001
- Status last verified
- Aug 2024
- First submitted
- 28 May 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Hu K, Shah P, Nguyen MC, McCluskey C, Kane A, Ove R, Willey CD, Katz S, Marathe O, Valentin S, Frustino J, Villa A, Spencer S, Holtzapfel C, Treister N, Lalla RV. Randomized, double-blind, sham-controlled trial of an intraoral photobiomodulation device for oral mucositis and associated complications due to radiotherapy for head and neck cancer. Support Care Cancer. 2026 Jun 26;34(7):696. doi: 10.1007/s00520-026-10904-7.
PubMed 42360517
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03972527
- Acronym / sponsor ID
- LLD-001
- Conditions
- Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Radiation, Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy, Head and Neck Cancer
- Keywords
- photobiomodulation, LLLT (low-level laser therapy), low-level laser therapy, oral mucositis, wound healing, radiation therapy, chemotherapy, antineoplastic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- MuReva Phototherapy Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.
| Arm | Type | Receives |
|---|---|---|
| Active Device Treatment Cohort - Chemoradiation therapy | Active comparator | Device: Photobiomodulation, Other: Routine Oral Care and AnalgesiaThe 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 comparator | Other: Routine Oral Care and AnalgesiaThe 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 comparator | Device: Photobiomodulation, Other: Routine Oral Care and AnalgesiaThe 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 comparator | Other: Routine Oral Care and AnalgesiaThe 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: low-level laser therapyProvide photobiomodulation therapy to subjects prior to each radiation therapy session. | Device | Active Device Treatment Cohort - Chemoradiation therapy, Active Device Treatment Cohort - Radiation therapy only |
| Routine Oral Care and AnalgesiaAlso: Pain medication, oral rinsesStandard oral care, oral hygiene and oral pain protocols | Other | Active Device Treatment Cohort - Chemoradiation therapy, Active Device Treatment Cohort - Radiation therapy only, Sham Device Treatment Cohort- Chemoradiation therapy, Sham Device Treatment Cohort- Radiation therapy only |
Primary outcome
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.
2 secondary outcomes
World Health Organization (WHO) Oral Toxicity Scale at week 6
Time frame: approximately 6 weeks after patient begins radiation therapy
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 42360517Hu K, Shah P, Nguyen MC, McCluskey C, Kane A, Ove R, Willey CD, Katz S, Marathe O, Valentin S, Frustino J, Villa A, Spencer S, Holtzapfel C, Treister N, Lalla RV. Randomized, double-blind, sham-controlled trial of an intraoral photobiomodulation device for oral mucositis and associated complications due to radiotherapy for head and neck cancer. Support Care Cancer. 2026 Jun 26;34(7):696. doi: 10.1007/s00520-026-10904-7.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and Routine Oral Care and Analgesia in people with Oral Mucositis (Ulcerative) and Oral Mucositis (Ulcerative) Due to Radiation, run by MuReva Phototherapy Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.