Low-Level Laser Therapy for Prevention of Oral Mucositis

Inclusion Criteria

• Willing and able to understand and sign informed consent form approved by the HRPO.
• Males or females greater than or equal to 18 years old.
• Biopsy-proven HNC including cancers of the nasopharynx, oropharynx, larynx, hypopharynx, or HNC of unknown primary origin amenable to therapy with radiation and concurrent chemotherapy.
• Patients who are planned to receive definitive or adjuvant radiotherapy with concurrent platinum-based chemotherapy.
• Patients whose clinical treatment plans include a continuous course of external beam radiotherapy by intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), given as a cumulative dose of 5000 - 7000 cGy in single daily fractions of 180 - 200 cGy, combined with a concurrent course of weekly or tri-weekly cisplatin or carboplatin chemotherapy.
• Karnofsky performance status score >60.
• Female subjects of child-bearing potential must have a negative pregnancy test prior to enrollment.

Exclusion Criteria

• Subject has evidence of current mucositis, mucosal ulceration, or unhealed surgical wounds from surgical resection or biopsy.
• Prior radiation to the head and neck.
• Patients with gross tumor involvement of the oral cavity or oral mucosa.
• Subjects planned to receive altered fractionation radiotherapy or multiple fractions per day
• Subject is using a pre-existing feeding tube for nutritional support at the time of study entry.
• Women who are pregnant or breast-feeding.
• Subject plans to receive concurrent chemotherapy, other than the regimens specified in the inclusion criteria.
• Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
• Patients who have a contraindication to radiation therapy.
• Patients enrolled on another investigational trial for oral mucositis prevention.
• Life expectancy of less than 3 months.
• Unable or unwilling to adhere to study-specified procedures