Low-Level Laser Therapy for Prevention of Oral Mucositis

David A. Clump, MD, PhD47 enrolled

Overview

The overall purpose of this study is 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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Mucositis

Interventions

Low Level Laser TherapyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Shadyside Department of Radiation Oncology

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis

Percentage of participants with severe oral mucositis per the World Health Organization (WHO grade 3-4) (ulcerative lesions of the oral mucosa) in patients treated to a cumulative radiation dose of at least 5000 cGy.

Time frame: Up to 1 year

Percentage of Participants With Severe (CTCAE v. 4.0 Grade 3-5) Oral Mucositis

The Percentage of participants with severe Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0 grade 3-5) oral mucositis in patients treated to a cumulative radiation dose of at least 5000 cGy.

Time frame: Up to 1 year

Secondary Outcomes

Time to Onset of Oral Mucositis

Time to onset of severe oral mucositis following the initiation of radiotherapy. per Common Terminology Criteria for Adverse Events (CTCAE v. 4.0 grade 3-4) oral mucositis following the initiation of radiotherapy.

Time frame: Up to 1 year

Mean Cumulative Radiation Dose

Mean cumulative radiation dose at time of onset of severe oral mucositis per Common Terminology Criteria for Adverse Events (CTCAE v. 4.0 grade 3-4)

Time frame: Up to 1 year

Duration of Oral Mucositis

Time from onset of severe oral mucositis per Common Terminology Criteria for Adverse Events (CTCAE v. 4.0 grade 3-4). The duration of SOM is calculated as the time in days between the onset of SOM to the time when the patient is first found to recover from SOM. If the patient do not recover from SOM, the duration is censored at the last observation time.

Time frame: Up to 1 year

Percentage of Participants With Feeding Tube Replacement

Data from ClinicalTrials.gov

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