Clinical trial NCT02723604: 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: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-30
Enrollment: 25
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 oral mucositis (OM) to 20%. We plan to enroll 25 patients at our institution in 12 months after the trial opens.

Eligibility criteria: Inclusion Criteria:

* Willing and able to understand and sign informed consent form approved by the institutional review board (IRB)
* Males or females greater than or equal to 18 years old
* Biopsy-proven head and neck cancer (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 centigray (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 patients of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

* Patient 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
* Patient planned to receive altered fractionation radiotherapy or multiple fractions per day
* Patient is using a pre-existing feeding tube for nutritional support at the time of study entry
* Women who are pregnant or breast-feeding
* Patient 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: Number of Participants With Severe (Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v. 4.0] Grade 3-5 Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Severe World Health Organization [WHO] (Grade 3-4) Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy
timeFrame: From beginning of therapy up to 3 months after completion of therapy
Secondary outcomes:
measure: Change in OM-related QOL Assessed Using FACT Questionnaire
timeFrame: From beginning of therapy up to completion of therapy
measure: Duration of Oral Mucositis
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Any Grade Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS)
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Trismus Assessed by Measurement of Interincisal Distance
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Xerostomia Assessed by CTCAE v. 4.0
timeFrame: Up to 3 months after completion of therapy
measure: Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Time to Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis Following the Initiation of Radiotherapy
timeFrame: From beginning of therapy up to 3 months after completion of therapy
Other outcomes:
measure: Amount of Narcotic Analgesia Use During Treatment
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Breaks in Treatment
timeFrame: Date of completion of chemoradiation therapy
measure: Percent Change in Body Weight During the Course of Treatment
timeFrame: From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy
measure: Number of Participants Who Require Feeding Tube Placement During Treatment (Excluding Patients Who Received a Prophylactic Feeding Tube Prior to the Initiation of Therapy)
timeFrame: At the date of completion of chemoradiation therapy
measure: Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by Schedule of Chemotherapy Given Weekly Versus Every 3 Weeks
timeFrame: From beginning of therapy up to 3 months after completion of therapy
measure: Time to Reach Planned Dose of Radiation Therapy
timeFrame: From the beginning of therapy up to completion of therapy (9 weeks maximum)
Locations:
city: Detroit
country: United States
facility: Wayne State University/Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Harold Kim
role: PRINCIPAL_INVESTIGATOR
References: