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.
- Male or female patients ≥ 18 years of age
- Karnofsky performance status > 70
- Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx
- No prior radiotherapy to the head and neck region.
- No previous systemic chemotherapy or targeted therapy
- Must be aware of the neoplastic nature of his/her disease and willingly provide
written, informed consent after being informed of the procedure to be followed, the
nature of the therapy, alternatives, potential benefits, side-effects, risks and
- Patients using standard therapies for cetuximab-induced acne-form rash will be
- Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT)
or other staging studies
- Any co-morbidity or condition of sufficient severity to limit full compliance with
the protocol per assessment by the investigator
- Concurrent serious infection
- Continued use of Niacin