Photobiomodulation for Oral Mucositis

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

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special light therapy device that fits in the mouth to help reduce mouth sores in adults with certain types of mouth and throat cancer who are receiving radiation therapy. The light helps heal and reduce the severity of these sores.

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 data supports the effectiveness of the treatment MuReva Phototherapy System for oral mucositis?

Research shows that photobiomodulation, which is a type of light therapy, is effective in treating oral mucositis, a painful mouth condition often caused by cancer treatments. Studies have found that this therapy can help reduce pain and speed up healing in patients with oral mucositis. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

Photobiomodulation therapy (PBMT) is considered safe for humans, as it has been used effectively to prevent and treat oral mucositis, a painful condition, in patients undergoing treatments like hematopoietic stem cell transplantation. ^{1 3 4 6 7}

How is the MuReva Phototherapy System treatment different from other treatments for oral mucositis?

The MuReva Phototherapy System uses photobiomodulation, a light-based therapy, to treat oral mucositis, which is different from traditional treatments that may rely on medications or mouthwashes. This therapy is unique because it uses specific wavelengths of light to reduce pain and inflammation, promoting healing without the need for drugs. ^{1 3 5 8 9}

Research Team

Nancy B Lipko, MD MBA

Principal Investigator

MuReva Phototherapy Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of photobiomodulation in the treatment of oral mucositis in patients undergoing antineoplastic therapy: systematic review and meta-analysis. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical use of photobiomodulation for the prevention and treatment of oral mucositis: the real-life experience of MASCC/ISOO members. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Antimicrobial photodynamic therapy for the treatment of oral mucositis-A comparative study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Path to an Evidence-Based Treatment Protocol for Extraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Photobiomodulation: a promising innovative approach for preventing oral mucositis in patients undergoing hematopoietic stem cell transplantation. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

High-power laser photobiomodulation therapy for immediate pain relief of refractory oral mucositis. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

Therapeutic Outcomes of Photobiomodulation in Cancer Treatment-induced Oral Mucositis: A Systematic Review. [2023]