NCT03972527

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

Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: MuReva Phototherapy Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the severity of oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving radiation therapy with or without concurrent chemotherapy.

Detailed description

Study Design: A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study. Protocol-eligible subjects will be randomized in a 1:1 allocation to receive either the active MuReva Phototherapy System or a sham control. Both the subjects and clinician evaluating the patients will be blinded to the treatment assignments. The sham device will be placed in the patient's mouth and operated in the same manner as the active device, but not deliver any therapy. Subjects will begin device treatment sessions on the first day of radiation treatment (RT) and will continue to receive once daily treatments prior to RT with their assigned device for 5 days per week for the duration of their RT treatment (approximately 6 to 8 weeks, for a total of 30 to 40 device sessions depending on the standard of care regimen for the type of cancer). Each device treatment session will last approximately 10 minutes in total. Light therapy parameters for the MuReva Phototherapy System will be as follows for all subjects receiving active light therapy: 660nm, 2-12 J/cm2 nominal fluence. Subjects who stay on RT treatment past 6 weeks will continue to receive treatment with their assigned devices up through 8 total weeks of treatment (for a maximum total of 40 phototherapy sessions). In addition, all subjects, regardless of randomization, will be kept on standard oral care, oral hygiene and oral pain protocols. 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 (i.e., 5 days during each of the 6-8 RT treatment weeks). Weekly, subjects will be evaluated for oral mucositis and for device safety. The weekly assessments will continue through the final RT session. A post-therapy assessment will be done approximately 2 weeks after completion of RT. At the conclusion of this assessment each subject's participation in the study will be complete.

Conditions

• Oral Mucositis (Ulcerative)
• Oral Mucositis (Ulcerative) Due to Radiation
• Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Photobiomodulation	Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
OTHER	Routine Oral Care and Analgesia	Standard oral care, oral hygiene and oral pain protocols

Timeline

• Start date: 2022-08-05
• Primary completion: 2024-06-26
• Completion: 2024-07-18
• First posted: 2019-06-03
• Last updated: 2024-08-21

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study