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

NCT03972527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • MuReva Phototherapy Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2024-06-26
Completion
2024-07-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972527 on ClinicalTrials.gov