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Phototherapy

Photobiomodulation for Oral Mucositis

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 weeks after patient begins radiation therapy

Awards & highlights

Study Summary

This trial is testing a new light delivery system to see if it can reduce the severity of oral mucositis in cancer patients receiving radiation therapy.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

MuReva Phototherapy Inc.Lead Sponsor

Nancy B Lipko, MD MBAStudy DirectorMuReva Phototherapy Inc.

Media Library

MuReva Phototherapy System (Phototherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03972527 — N/A

Head and Neck Cancers Research Study Groups: Sham Device Treatment Cohort- Radiation therapy only, Active Device Treatment Cohort - Radiation therapy only, Active Device Treatment Cohort - Chemoradiation therapy, Sham Device Treatment Cohort- Chemoradiation therapy

Head and Neck Cancers Clinical Trial 2023: MuReva Phototherapy System Highlights & Side Effects. Trial Name: NCT03972527 — N/A

MuReva Phototherapy System (Phototherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03972527 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots currently available to join this research project?

"Affirmative. According to the records hosted on clinicaltrials.gov, this research study is actively accepting participants; its initial posting was August 5th 2022 and it has had a recent update as of August 30th 2022. The investigation necessitates 82 individuals at 7 different medical centres."

Answered by AI

How many research facilities are executing this trial at present?

"At the moment, 7 medical sites have opened their doors to enrolling patients. These sites are situated in Buffalo, Cincinnati and Cleveland as well as other nearby cities. It is recommended that individuals considering enrollment select a clinic within close proximity so they can reduce travelling requirements."

Answered by AI

What is the total population of subjects participating in this clinical trial?

"Indeed, clinical trials.gov has the details for this medical experiment listed as actively recruiting. It was first posted on August 5th 2022 and most recently revised on August 30th 2022 with a goal of 82 patients from 7 different sites."

Answered by AI

What are the primary aims of this investigation?

"This 6 week long study will seek to determine the prevalence of severe oral mucositis (WHO grade 3 and 4) at week 6 following initiation of radiation therapy. Along with this, the Secondary objectives include assessing World Health Organization Oral Toxicity Scale, overall quality of life via the Oral Mucositis Weekly Questionnaire-Head and neck cancer survey, as well as analgesic usage based on steps 1-3 outlined in The World Health Organization Analgesic Ladder."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients

2022. "Photobiomodulation to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Head & Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03972527.

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