Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma

This single-arm phase I/II study establishes the safety and efficacy of low level laser
therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing
radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives
include assessment of patient-reported quality of life data, pain parameters and dermatologic
quality of life responses. The target population is patients with histologically proven
squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are
candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and
concurrent radiation therapy.

Patients are required to have a favorable performance status (KPS greater than or equal to
70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to
provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients
will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least
nine treatment sites in the head and neck region for a duration of 60 seconds to each site.
LLLT will be given three times in a week prior to, daily during the first week of, and at
least twice weekly thereafter during radiotherapy.

Information collected includes toxicity scoring and quality of life surveys. A retrospective
matched-pair design will be used to assess the rate of grade III complications compared to
patients treated previously without LLLT support, with an anticipated 20% reduction in the
risk of grade III dermatitis.