Status:
Recruiting
Disease Site:
Head and Neck
Official Title:
LLD-001 (MuReva): 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
NCT ID:
NCT#03972527
Link to Full Details:
Description:
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.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Dx w/pathologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, tonsil, or base of tongue
- Radiation tx fields include minimum of 50 Gy to at least two oral cavity sites
- CANNOT consume alcoholic beverages or use any tobacco or nicotine products with - exception of nicotine patches for duration of treatment
Exclusion Criteria:
- Currently receiving or previously received chemo or chemoradiotherapy in the past 2 years, and oral cavity has not yet fully recovered.
- Received Prior RT radiation to H&N
- Received neo-adjuvant or induction chemo for H&N Ca prior to start of RT (Radiation Therapy).
- Has 8 or more dental prostheses or implants
- **CANNOT receive meds indicated for the treatment and/or prevention of mucositis or receive/receiving meds with oral photoprotection indications
- Active infection in the oropharynx/oral cavity