What is the mechanism of action of this treatment?

Common treatments for head and neck cancers include surgery, radiation therapy, chemotherapy, and phototherapy. Phototherapy, such as the MuReva Phototherapy System, uses light to reduce inflammation and promote healing by stimulating cellular processes. This is particularly important for head and neck cancer patients as it can help manage and mitigate the side effects of radiation therapy, such as oral mucositis, thereby improving their quality of life and potentially enhancing the effectiveness of their overall treatment plan.

What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiotherapy and chemotherapy, often result in side effects like mucositis, xerostomia (dry mouth), pain, and difficulty swallowing. Phototherapy, including low-level laser therapy and photodynamic therapy, is being studied to reduce these side effects by promoting healing and reducing inflammation. While phototherapy is generally well-tolerated, potential side effects can include localized pain, burning, and blistering at the treatment site. Further studies are needed to fully understand the long-term safety and efficacy of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for head and neck cancers, including cetuximab, an EGFR-targeting monoclonal antibody, which has shown significant improvements in locoregional control and overall survival when added to definitive radiation therapy. While the MuReva Phototherapy System is being studied for its potential to reduce inflammation and promote healing in oral mucositis, specific FDA approvals for phototherapy in head and neck cancers are not detailed in the provided context. Broadly, treatments for head and neck cancers include chemoradiotherapy, bioradiotherapy, and various systemic therapies tailored to individual patient needs.

What other types of research exist?

Promising novel alternatives to the MuReva Phototherapy System for head and neck cancer patients include low-level laser therapy (LLLT) and hyperbaric oxygen therapy (HBO). Both have shown potential benefits in improving healing and reducing symptoms, although more extensive studies are needed to establish their efficacy definitively.

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Phototherapy

Photobiomodulation for Oral Mucositis

N/A

Waitlist Available

Research Sponsored by MuReva Phototherapy Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 weeks after patient begins radiation therapy

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects of photobiomodulation aren't detailed but may include discomfort from using the mouthpiece or potential reactions to light therapy such as tissue irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 22 years old or older.

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My radiation treatment plan includes at least 50 Gy to two parts of my mouth.

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I am scheduled for a specific type of radiation therapy for 6 to 8 weeks.

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I can take care of myself and am up and about more than half of my waking hours.

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I will not use any tobacco or nicotine products except for nicotine patches during my treatment.

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I have been diagnosed with a specific type of cancer in my mouth or throat.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am receiving initial chemotherapy for my Head and Neck cancer before radiation therapy.

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I am taking medication that requires me to avoid sunlight.

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I have another type of cancer that is not under control.

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I have received radiation therapy to my head or neck.

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I can't open my mouth wider than 30mm.

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I have a condition like uncontrolled diabetes that could affect wound healing.

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I am taking medication to prevent or treat mouth sores.

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I have mouth sores as graded by the WHO scale.

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I have a condition like Sjögren's syndrome affecting my saliva.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ difference between baseline and (approximately) 6 weeks after patient begins radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~difference between baseline and (approximately) 6 weeks after patient begins radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and difference between baseline and (approximately) 6 weeks after patient begins radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IThe primary effectiveness endpoint is the severity of oral mucositis at week 6 of radiation treatment according to the Oral Mucositis Index (OMI) score.

Secondary study objectives

Changes in overall quality of life over the 6-week treatment period

World Health Organization (WHO) Oral Toxicity Scale at week 6

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Active Device Treatment Cohort - Radiation therapy onlyActive Control2 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 therapyActive Control2 Interventions

Group III: Sham Device Treatment Cohort- Radiation therapy onlyPlacebo Group1 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 therapyPlacebo Group1 Intervention

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for head and neck cancers include surgery, radiation therapy, chemotherapy, and phototherapy. Phototherapy, such as the MuReva Phototherapy System, uses light to reduce inflammation and promote healing by stimulating cellular processes. This is particularly important for head and neck cancer patients as it can help manage and mitigate the side effects of radiation therapy, such as oral mucositis, thereby improving their quality of life and potentially enhancing the effectiveness of their overall treatment plan.

Photobiomodulation with low-level laser therapy reduces oral mucositis caused by head and neck radio-chemotherapy: prospective randomized controlled trial.Three photobiomodulation protocols in the prevention/treatment of radiotherapy-induced oral mucositis.Effect of low level helium-neon (He-Ne) laser therapy in the prevention & treatment of radiation induced mucositis in head & neck cancer patients.