Trial Outcomes & Findings for Low-Level Laser Therapy for Prevention of Oral Mucositis (NCT NCT02723604)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

From beginning of therapy up to 3 months after completion of therapy

Results posted on

2023-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Low Level Laser Therapy 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. Low Level Laser Therapy: 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.
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Low Level Laser Therapy 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. Low Level Laser Therapy: 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.
Overall Study ineligible	1
Overall Study never received treatment	1

Baseline Characteristics

Low-Level Laser Therapy for Prevention of Oral Mucositis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Age, Continuous	62.5 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
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	15 Participants

PRIMARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
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	10 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to completion of therapy

Population: 5 patients were missing either the beginning and/or completion of therapy QOL data

The QOL assessment taken at the beginning of therapy is subtracted from the QOL assessment taken at the completion of therapy. The QOL scale is the FACT Questionnaire. Measure on a scale of 0 to 4. 0 = not at all and 4= very much.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=18 Participants 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. Low Level Laser Therapy: 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.
Change in OM-related QOL Assessed Using FACT Questionnaire	2.3 units on a scale Interval 1.9 to 2.8

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Population: 15 of the 23 patients had at least 1 episode of oral mucositis. 2 patients had 2 distinct episodes of oral mucositis. Each instance was analyzed separately

Survival analysis was used to estimate the duration of oral mucositis. Patients were censored if oral mucositis not resolved by the end of the study.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=17 instances 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. Low Level Laser Therapy: 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.
Duration of Oral Mucositis	4 weeks Interval 4.0 to Kaplan-Meier estimation was used for this analysis. The 90% upper limit of the confidence interval did not cross 50%.

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Grade of oral mucositis assessed using the NCI CTCAE version 4.0

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Any Grade Oral Mucositis in Patients Treated to a Cumulative Radiation Dose of at Least 5000 cGy	23 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Variable is reported on the 1-5 CTCAE scale: 1. \- Mild 2. \- Moderate 3. \- Severe 4. \- Life-threatening 5. \- Death The maximum recorded severity is reported.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 Grade 1	0 participants
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 Grade 2	23 participants
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 Grade 3	0 participants
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 Grade 4	0 participants
Number of Participants With Dysgeusia Assessed by CTCAE v. 4.0 Grade 5	0 participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Variable is reported on the 1-5 CTCAE scale: 1. \- Mild 2. \- Moderate 3. \- Severe 4. \- Life-threatening 5. \- Death The maximum recorded severity is reported.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment Grade 1	2 Participants
Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment Grade 2	17 Participants
Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment Grade 3	4 Participants
Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment Grade 4	0 Participants
Number of Participants With Dysphagia Assessed by CTCAE v. 4.0 and Diet Assessment Grade 5	0 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Variable is reported on the 1-10 scale Higher values represent a worse outcome The maximum recorded severity is reported

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 1	0 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 2	0 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 3	2 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 4	0 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 5	5 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 6	2 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 7	2 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 8	5 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 9	4 Participants
Number of Participants With Pain as Assessed by the Visual Analogue Scale (VAS) 10	3 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Variable is reported on the 1-5 CTCAE scale: 1. \- Mild 2. \- Moderate 3. \- Severe 4. \- Life-threatening 5. \- Death The maximum recorded severity is reported.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 Grade 1	5 Participants
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 Grade 2	16 Participants
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 Grade 3	2 Participants
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 Grade 4	0 Participants
Number of Participants With Radiodermatitis Assessed by CTCAE v. 4.0 Grade 5	0 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Trismus is defined as a measurement of interincisal distance less than or equal to 30mm.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Trismus Assessed by Measurement of Interincisal Distance	2 Participants

SECONDARY outcome

Timeframe: Up to 3 months after completion of therapy

Variable is reported on the 1-5 CTCAE scale: 1. \- Mild 2. \- Moderate 3. \- Severe 4. \- Life-threatening 5. \- Death The maximum recorded severity is reported.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 Grade 1	2 Participants
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 Grade 2	17 Participants
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 Grade 3	4 Participants
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 Grade 4	0 Participants
Number of Participants With Xerostomia Assessed by CTCAE v. 4.0 Grade 5	0 Participants

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Population: 15 patients had severe oral mucositis; 3 were missing dose information

The reported dose is at the first incidence of severe oral mucositis.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=12 Participants 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. Low Level Laser Therapy: 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.
Mean Cumulative Radiation Dose at Time of Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis	53.5 Gray Interval 47.68 to 59.32

SECONDARY outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Survival analysis is used to analyze this endpoint

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Time to Onset of Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis Following the Initiation of Radiotherapy	NA weeks Interval 7.0 to The Kaplan-Meier curve and upper confidence limit did not cross 50%

OTHER_PRE_SPECIFIED outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Population: Data not collected

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date of completion of chemoradiation therapy

Population: Data not collected

Breaks in treatment defined as one of the following: Missing at least 1 chemotherapy treatment; dose reduction in planned cisplatin administration; OR 3 consecutive days of no radiation therapy secondary to mucositis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of enrollment until the date of completion of chemoradiation therapy, assessed up to 3 months after completion of therapy

The percent change in body weight was computed by subtracting the baseline weight from the weight after completion of treatment and dividing that quantity by the baseline weight. The confidence interval is estimated using the t distribution.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Percent Change in Body Weight During the Course of Treatment	-10.9 percent change in body weight Interval -13.0 to -8.7

OTHER_PRE_SPECIFIED outcome

Timeframe: At the date of completion of chemoradiation therapy

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants Who Require Feeding Tube Placement During Treatment (Excluding Patients Who Received a Prophylactic Feeding Tube Prior to the Initiation of Therapy)	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=23 Participants 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. Low Level Laser Therapy: 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.
Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy Treated with 70Gy & had OM	14 Participants
Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy Treated with 70Gy & did not have OM	6 Participants
Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy Treated with 50-69Gy & had OM	1 Participants
Number of Participants With Severe (CTCAE v. 4.0 Grade 3-4) Oral Mucositis by 5000 and 7000 cGy Treated with 50-69Gy & did not have OM	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From beginning of therapy up to 3 months after completion of therapy

Population: Data not collected

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From the beginning of therapy up to completion of therapy (9 weeks maximum)

Population: 1 patient is missing dose information; 5 did not reach planned dose

Kaplan-Meier methods are used to estimate time until reaching planned dose.

Outcome measures

Outcome measures
Measure	Experimental: Low Level Laser Therapy n=17 Participants 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. Low Level Laser Therapy: 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.
Time to Reach Planned Dose of Radiation Therapy	9 weeks Interval 8.0 to 9.0

Adverse Events

Experimental: Low Level Laser Therapy

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: Low Level Laser Therapy n=23 participants at risk 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. Low Level Laser Therapy: 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.
General disorders Dysphagia	100.0% 23/23 • Number of events 23 • Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.
General disorders Xerostomia	100.0% 23/23 • Number of events 23 • Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.
General disorders Dysgeusia	100.0% 23/23 • Number of events 23 • Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.
General disorders Trismus	8.7% 2/23 • Number of events 2 • Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.
General disorders Radiodermatitis	100.0% 23/23 • Number of events 23 • Adverse event data were collected from the beginning of treatment, up until 3 months after the completion of treatment.

Additional Information

Dr. Harold Kim

Barbara Ann Karmanos Cancer Institute

Phone: 313-576-9543

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place