Photobiomodulation for Oral Mucositis

No longer recruiting at 11 trial locations

Overseen By Vedang Kothari, BSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MuReva Phototherapy Inc.

Must not be taking: Mucositis medications, Oral photoprotection

Disqualifiers: Uncontrolled diabetes, Active infection, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the MuReva Phototherapy System, a new light therapy device, to determine its effectiveness in reducing oral mucositis, a painful mouth condition, in individuals undergoing radiation therapy for certain oral cancers. Participants will use a special mouthpiece connected to a light system designed to alleviate symptoms. The trial includes different groups to compare the real device with a placebo to ensure accurate results. Ideal participants have a confirmed diagnosis of squamous cell carcinoma in the oral area and are about to begin radiation therapy, with or without chemotherapy. As an unphased trial, this study allows participants to contribute to innovative research that may enhance future cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications for mucositis or those with oral photoprotection indications during the study.

What prior data suggests that the MuReva Phototherapy System is safe for reducing oral mucositis?

Research has shown that the MuReva Phototherapy System is generally safe. In a previous study, most participants tolerated the treatment well, with about 97% of sessions completed without issues. No device-related side effects were reported, indicating its safety.

The device uses light therapy to alleviate mouth sores that can occur during cancer treatment. This therapy has been tested and found safe, with no major adverse effects. The results are encouraging for those considering participation in a clinical trial with this system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MuReva Phototherapy System because it offers a new approach to treating oral mucositis, a common and painful side effect of radiation and chemoradiation therapy. Unlike standard treatments that primarily focus on symptom management, like mouthwashes and pain medications, MuReva uses photobiomodulation. This involves the use of light therapy to potentially promote healing and reduce inflammation in the mouth. The treatment is quick, taking just a few minutes daily, and could significantly enhance patient comfort and recovery during cancer treatment.

What evidence suggests that the MuReva Phototherapy System is effective for reducing oral mucositis?

Research has shown that the MuReva Phototherapy System might help reduce painful mouth sores caused by radiation and chemotherapy. Early studies found that the device is safe, easy to use, and significantly improved the severity of these mouth sores. In this trial, participants will join different treatment arms, including active device and sham device cohorts, to evaluate the MuReva Phototherapy System's effectiveness. The treatment uses a special light to heal mouth tissue, and early results are promising. Although more research is needed to confirm these findings, the initial data is encouraging for those undergoing radiation therapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Nancy B Lipko, MD MBA

Principal Investigator

MuReva Phototherapy Inc.

Are You a Good Fit for This Trial?

Adults over 22 with squamous cell carcinoma in the oral cavity or related areas, scheduled for radiation therapy, possibly with chemotherapy. They must be able to use a mouthpiece daily and not have conditions affecting wound healing or severe dental issues. Tobacco, nicotine products (except patches), cannabis, and illicit drugs are prohibited during treatment.

Inclusion Criteria

I am on chemotherapy that includes Cisplatin or Carboplatin, with or without Paclitaxel.

For the entire duration of their treatment, the subject will not use any inhaled cannabis products or any illicit drugs

I am 22 years old or older.

Exclusion Criteria

I do not have an active infection in my mouth or throat.

Subject is receiving, or has received in the last 30 days, an investigational treatment, therapy, or medical device outside of this clinical study protocol

I've had chemotherapy or chemoradiotherapy in the last 2 years and my mouth hasn't fully healed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive daily photobiomodulation therapy sessions prior to radiation therapy for 5 days per week

6-8 weeks

30-40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MuReva Phototherapy System

Trial Overview The trial is testing the MuReva Phototherapy System's safety and effectiveness in reducing oral mucositis severity in head & neck cancer patients undergoing radiation therapy. It involves using a light delivery mouthpiece alongside routine care compared to standard treatments.

How Is the Trial Designed?

Group I: Active Device Treatment Cohort - Radiation therapy only Active Control 2 Interventions

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.

Group II: Active Device Treatment Cohort - Chemoradiation therapy Active Control 2 Interventions

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.

Group III: Sham Device Treatment Cohort- Radiation therapy only Placebo Group 1 Intervention

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.

Group IV: Sham Device Treatment Cohort- Chemoradiation therapy Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

MuReva Phototherapy Inc.

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

Photobiomodulation therapy (PBMT) is a safe and effective treatment for oral mucositis, a painful complication following hematopoietic stem cell transplantation.

Extraoral delivery of PBMT offers clinical advantages but requires careful dosimetric planning to ensure effective treatment, as light must pass through additional tissue layers before reaching the oral mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Path to an Evidence-Based Treatment Protocol for Extraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis. Adnan, A., Yaroslavsky, AN., Carroll, JD., et al.[2022]

In a study involving 73 cancer patients undergoing radiotherapy, the Photobiomodulation protocol in Group 1 (660 nm, 15 mW, 3.8 J/cm2) was found to significantly delay the onset of grade II oral mucositis compared to the other protocols, indicating its superior efficacy.

Patients in Group 1 also reported lower pain scores related to oral mucositis, suggesting that this Photobiomodulation protocol not only reduces the severity of mucositis but also alleviates associated pain more effectively than the other treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. de Carvalho, PAG., Lessa, RC., Carraro, DM., et al.[2021]

Photobiomodulation is effective in reducing the severity of oral mucositis, as shown in a systematic review of 6 studies involving 299 patients, where the laser treatment group had a greater chance of improvement compared to the control group.

While photobiomodulation showed promise in reducing oral mucositis severity, the analysis of its effects on the duration of lesions and pain reduction was inconclusive due to high variability among the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of photobiomodulation in the treatment of oral mucositis in patients undergoing antineoplastic therapy: systematic review and meta-analysis. Cruz, AR., Minicucci, EM., Betini, M., et al.[2023]

Photobiomodulation (PBM) therapy is recommended for the prevention of oral mucositis (OM) in cancer patients undergoing specific treatments, such as hematopoietic stem cell transplantation and head and neck radiotherapy, based on a systematic review of the literature.

Currently, there is insufficient evidence to provide guidelines for the treatment of established OM or chemotherapy-related OM, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Zadik, Y., Arany, PR., Fregnani, ER., et al.[2021]

High-power laser photobiomodulation (PBM) therapy significantly reduced pain in 25 cancer patients with refractory oral mucositis, with 94% of treatment sessions resulting in immediate pain relief.

Patients experienced an average pain reduction of 72% for chemotherapy-induced mucositis and 60% for radiotherapy-induced mucositis, with effects lasting around 6 days, indicating PBM as a safe and effective non-drug option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. Finfter, O., Cohen, R., Hanut, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03972527

Study Details | NCT03972527 | Photobiomodulation to ... 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. murevapt.com murevapt.com/

MuReva Phototherapy MuReva Phototherapy is developing a photobiomodulation technology designed to treat radiation and chemotherapy induced mucositis.

3. murevapt.com murevapt.com/our-clinical-study/

MuReva Phototherapy - Our Clinical Study The primary effectiveness endpoint is the severity of oral mucositis at week 6 of treatment according to the Oral Mucositis Index (OMI) score. Secondary Outcome ...

4. marketwatch.com marketwatch.com/press-release/mureva-phototherapy-presents-data-during-2025-astro-meeting-confirming-safety-and-efficacy-of-the-company-s-led-based-photobiomodulation-therapy-device-fad53f4e?gaa_at=eafs&gaa_n=AWEtsqc8SYCJZwaYBGquGl_M7F1WNq-GvF6ciouV6HV3gq0sgHJ2Qk8XNVFq&gaa_ts=69040197&gaa_sig=knH2hqRmxSFfZRciUSPhFvgfT1Ol3OzJhHcnxvtJP6dwiA_4yRsUBGhl6Xn2pFwP43lLYHmfNDn2i624UACefQ%3D%3D

MuReva Phototherapy Presents Data during 2025 ASTRO ... Results from the study demonstrated that the use of the MuReva device was safe, well tolerated, with clinically meaningful outcomes. Treatment ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624001469

167 A Pilot Study of HNC Patients Treated Daily with an ... The (Sponsor) Phototherapy System shows encouraging results in a pilot cohort, is well tolerated for daily treatments in a clinic setting and is safe ...

6. marketwatch.com marketwatch.com/press-release/mureva-phototherapy-presents-data-during-2025-astro-meeting-confirming-safety-and-efficacy-of-the-company-s-led-based-photobiomodulation-therapy-device-fad53f4e?gaa_at=eafs&gaa_n=AWEtsqfo3dj1wG2MWocK1avD0qPlJxbDtnJKm1J_as1YBX8fLOP0JBgg1eCY&gaa_ts=6904018a&gaa_sig=S_FHgyf7Q51A8H3TYrLJPVS4Q9_i9_tNaa4cgg092i-xPP1Z8EW5hFCU2q38Ux9-93uh9qbkmiJ5zkSeys8s2g%3D%3D

MuReva Phototherapy Presents Data during 2025 ASTRO ... Results from the study demonstrated that the use of the MuReva device was safe, well tolerated, with clinically meaningful outcomes. Treatment ...

7. murevapt.com murevapt.com/2023/10/astro2023/

MuReva Phototherapy presents data from pilot study of ... Treatment with the PBM device was well tolerated (97% of treatments were completed in full), safe with no device-related adverse events and 97% ...