Trial Outcomes & Findings for Low-Level Laser Therapy for Prevention of Oral Mucositis (NCT NCT02682992)
NCT ID: NCT02682992
Last Updated: 2022-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2022-04-13
Participant Flow
Participant milestones
| Measure |
Low Level Laser Therapy
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Overall Study
STARTED
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47
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Overall Study
COMPLETED
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47
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Level Laser Therapy for Prevention of Oral Mucositis
Baseline characteristics by cohort
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Age, Continuous
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60.5 years
n=99 Participants
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Sex: Female, Male
Female
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6 Participants
n=99 Participants
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Sex: Female, Male
Male
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41 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=99 Participants
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Race (NIH/OMB)
White
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40 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=99 Participants
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Head Neck Origin
Hypopharynx
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1 Participants
n=99 Participants
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Head Neck Origin
Larynx
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8 Participants
n=99 Participants
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Head Neck Origin
Nasopharynx
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3 Participants
n=99 Participants
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Head Neck Origin
Oropharynx
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33 Participants
n=99 Participants
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Head Neck Origin
Unknown
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2 Participants
n=99 Participants
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Tobacco History
Tobacco use - No
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25 Participants
n=99 Participants
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Tobacco History
Tobacco use - Yes
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22 Participants
n=99 Participants
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Alcohol History
Alcohol use - No
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18 Participants
n=99 Participants
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Alcohol History
Alcohol use - Yes
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29 Participants
n=99 Participants
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Positive Karnofsky Performance Status
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47 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing severe 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.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Percentage of Participants With Severe (WHO Grade 3-4) Oral Mucositis
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23 percentage of participants
Interval 14.9 to 34.8
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PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing severe 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.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Percentage of Participants With Severe (CTCAE v. 4.0 Grade 3-5) Oral Mucositis
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23 percentage of participants
Interval 14.9 to 34.8
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Includes only treated patients experiencing severe 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.
Outcome measures
| Measure |
Low Level Laser Therapy
n=11 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Time to Onset of Oral Mucositis
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NA days
Median number of days and 95% Confidence Interval were not reached due to insufficient number of participants with events.
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Includes only treated patients experiencing severe oral mucositis.
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)
Outcome measures
| Measure |
Low Level Laser Therapy
n=11 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Mean Cumulative Radiation Dose
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56 Gy
Standard Deviation 12.8624
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Includes only treated patients experiencing severe 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.
Outcome measures
| Measure |
Low Level Laser Therapy
n=11 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Duration of Oral Mucositis
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24 days
Interval 14.0 to 89.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients who required feeding tube placement.
Percentage of participants who require feeding tube placement during treatment.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Percentage of Participants With Feeding Tube Replacement
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36 percentage of participants
Interval 25.7 to 48.2
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing trismus.
Percentage of Participants with trismus (reduced opening of the jaws determined via measurement of interincisal distance). The interincisal distance will be measured in millimeters at the patient's maximum comfortable extent of mouth opening.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Percentage of Participants With Trismus
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26 percentage of participants
Interval 15.3 to 39.5
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients that completed Fact QoL assessments.
This measure is based on a self-administered questionnaire. Responses to each item were on a Likert scale score ranging from 0 to 4. The individual responses were summed to compute subscale scores, and the subscales to compute overall total scores, with higher scores indicating better Quality of Life. FACT-HN includes 2 parts - FACT-G and FACT-HN. The basic FACT-G (general) is comprised of 27 items (0-108). Subscales include Physical Well-Being (0-28), Social/Family Well-Being (0-28), Emotional Well-Being (0-24), and Functional Well-Being, (0-28). Two "Relationship with physician" items (subscale score min/max = 0-8) were added to the FACT-G in this trial, for a total of 29 FACT-G items (total min/max = 0-116). The FACT-HN is comprised of 12 head and neck specific items (0-48). Thus, the overall total possible score range was 0-164. The FACT Head \& Neck Trial Outcome Index is a composite score which includes only physical, functional, and FACT-HN, thus a score range from 0-104.
Outcome measures
| Measure |
Low Level Laser Therapy
n=36 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
EMOTIONAL WELL BEING (EWB)
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20.9167 score on a scale
Interval 18.2738 to 22.0909
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
PHYSICAL WELL BEING (PWB)
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21.5417 score on a scale
Interval 17.869 to 23.875
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
SOCIAL/FAMILY WELL BEING (SWB)
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24.3654 score on a scale
Interval 22.0833 to 26.7424
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
FUNCTIONAL WELL BEING (FWB)
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18.7708 score on a scale
Interval 11.6845 to 21.6307
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
FACT-G total score (FACTG)
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84.9028 score on a scale
Interval 73.9515 to 92.0182
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
FACT HN
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21.7035 score on a scale
Interval 18.75 to 25.6083
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
FACT-G with FACT HN total score
|
107.403 score on a scale
Interval 89.0835 to 117.246
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Quality of Life Via Functional Assessment of Cancer Therapy Head & Neck Cancer (FACT-HN) Questionnaire
FACT Head & Neck Trial Outcome Index
|
62.4470 score on a scale
Interval 46.4815 to 69.5091
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing oral mucositis.
The percentage of participants with oral mucositis Common Terminology Criteria for Adverse Events (CTCAE v. 4.0 - all grades) in patients treated to a cumulative radiation dose of at least 5000 cGy.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Oral Mucositis
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96 percentage of participants
Interval 87.9 to 98.6
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SECONDARY outcome
Timeframe: Up to 1 yearPercentage of participants with dysphagia per Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0) and via diet assessment.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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Percentage of Participants With Dysphagia
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100 percentage of participants
Interval 94.6 to 100.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing xerostomia.
Percentage of participants with xerostomia (oral dryness) per Common Terminology Criteria for Adverse Events (CTCAE) CTCAE v. 4.0.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Xerostomia
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100 percentage of participants
Interval 94.6 to 100.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing dysgeusia.
Percentage of participants with dysgeusia (altered taste with/without change in diet (e.g., oral supplements); noxious or unpleasant taste; loss of taste) per Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0).
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Dysgeusia
|
100 percentage of participants
Interval 94.6 to 100.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing radiodermatitis.
Percentage of participants with radiodermatitis (skin response to ionizing radiation exposure/therapy ranging from erythematous rash to desquamation and necrosis) per Common Terminology Criteria for Adverse Events (CTCAE, v. 4.0).
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Radiodermatitis
|
100 percentage of participants
Interval 94.6 to 100.0
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing mouth pain.
Percentage of participants with mouth pain. Mouth pain severity will be assessed using a standard 0-10 scale, with higher scores indicating greater pain.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Mouth Pain
|
94 percentage of participants
Interval 85.1 to 97.4
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Treated patients experiencing throat pain.
Percentage of participants with throat pain. Throat pain severity will be assessed using a standard 0-10 scale, with higher scores indicating greater pain.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Percentage of Participants With Throat Pain
|
96 percentage of participants
Interval 87.9 to 98.6
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SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Treated patients that used a narcotic analgesic.
Percentage of patients using narcotic analgesia during treatment.
Outcome measures
| Measure |
Low Level Laser Therapy
n=47 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Narcotic Analgesia Use
|
55 percentage of participants
Interval 41.0 to 69.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Treated patients that experienced breaks in chemoradiotherapy.
Mean number of breaks in chemoradiotherapy with LLLT use.
Outcome measures
| Measure |
Low Level Laser Therapy
n=38 Participants
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
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|---|---|
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Breaks in Chemoradiotherapy
|
47.7368 events
Standard Deviation 5.19191
|
Adverse Events
Low Level Laser Therapy
Serious events: 18 serious events
Other events: 47 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Low Level Laser Therapy
n=47 participants at risk
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
|
|---|---|
|
Gastrointestinal disorders
Oral Mucositis
|
23.4%
11/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Gastrointestinal disorders
dysphagia
|
38.3%
18/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Gastrointestinal disorders
dry mouth
|
2.1%
1/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Injury, poisoning and procedural complications
dermatitis
|
4.3%
2/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
Other adverse events
| Measure |
Low Level Laser Therapy
n=47 participants at risk
Patients that received 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: 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 performed to identify any areas of mucositis. Patients that develop intraoral lesions are targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
|
|---|---|
|
Gastrointestinal disorders
Oral Mucositis
|
72.3%
34/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Gastrointestinal disorders
dysphagia
|
61.7%
29/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Gastrointestinal disorders
dry mouth
|
97.9%
46/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Nervous system disorders
dysgeusia
|
100.0%
47/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Injury, poisoning and procedural complications
dermatitis
|
95.7%
45/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Gastrointestinal disorders
oral pain
|
93.6%
44/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
95.7%
45/47 • Adverse Events monitored up to 24 months, All-Cause Mortality monitored up to 36 months
Adverse Events: Grade 1 and Grade 2 events per CTCAE v4.0 Serious Adverse Events: Grade 3 and Grade 4 events per CTCAE v4.0
|
Additional Information
Barbara Stadterman, MPH, Regulatory Specialist Supervisor
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place