Photobiomodulation for Oral Mucositis

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: MuReva Phototherapy Inc.

No Placebo Group

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.

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.

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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.

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Treatment Details

Interventions

MuReva Phototherapy System (Phototherapy)

Trial OverviewThe 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

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