Clinical trial NCT02682992: Low-Level Laser Therapy for Prevention of Oral Mucositis
Official title: A Phase II Prospective Trial of Low-Level Laser Therapy for Prevention of Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucositis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis
timeFrame: Up to 1 year
measure: Percentage of Participants With Severe (CTCAE v. 4.0 Grade 3-5) Oral Mucositis
timeFrame: Up to 1 year
Secondary outcomes:
measure: Time to Onset of Oral Mucositis
timeFrame: Up to 1 year
measure: Mean Cumulative Radiation Dose
timeFrame: Up to 1 year
measure: Duration of Oral Mucositis
timeFrame: Up to 1 year
measure: Percentage of Participants With Feeding Tube Replacement
timeFrame: Up to 1 year
measure: Percentage of Participants With Trismus
timeFrame: Up to 1 year
measure: Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
timeFrame: Up to 1 year
measure: Percentage of Participants With Oral Mucositis
timeFrame: Up to 1 year
measure: Percentage of Participants With Dysphagia
timeFrame: Up to 1 year
measure: Percentage of Participants With Xerostomia
timeFrame: Up to 1 year
measure: Percentage of Participants With Dysgeusia
timeFrame: Up to 1 year
measure: Percentage of Participants With Radiodermatitis
timeFrame: Up to 1 year
measure: Percentage of Participants With Mouth Pain
timeFrame: Up to 1 year
measure: Percentage of Participants With Throat Pain
timeFrame: Up to 1 year
measure: Narcotic Analgesia Use
timeFrame: Up to 2 years
measure: Breaks in Chemoradiotherapy
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Department of Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: UPMC Department of Radiation Oncology
name: David A Clump, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: