Low-Level Laser Therapy for Prevention of Oral Mucositis

A phase II, single-arm trial to examine the efficacy of prophylactic low-level laser therapy
(LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving
combined modality therapy consisting of chemotherapy and radiation therapy for head and neck
cancer.

Patients meeting the eligibility criteria will be enrolled to receive prophylactic LLLT in
addition to standard of care measures for oral mucositis or other toxicity of therapy. The
radiation and chemotherapy dose, schedule, modality, technique, and any required adjustments
will not be influenced by this protocol and will follow standard existing institutional
practices.

Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may
be delivered either immediately prior to or after the patient's daily fraction of
radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute
along the buccal mucosa on each side and intraorally for one minute to the tongue and soft
palate. During each LLLT treatment session a thorough oral exam will be performed to identify
any areas of mucositis. If the patient should develop intraoral lesions they will be targeted
directly with the intraoral probe for one minute to each site of mucositis. The laser
settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for
an energy of 4.5 J.

Patients will be evaluated prior to therapy, weekly during therapy, two weeks after the
completion of therapy, and three months after the completion of therapy. During each
assessment, the following toxicities will be assessed: pain, mucositis, dysphagia,
xerostomia, dysgeusia, dermatitis, trismus, and quality of life.

Previous studies indicate that approximately 40% of patients will experience severe mucositis
with radiation and concurrent chemotherapy. The hypothesis in this trial is that the addition
of LLLT to this treatment regimen will decrease the rate of severe acute OM to 20%. We plan
to enroll 50 patients at our institution.

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