Trial Outcomes & Findings for Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma (NCT NCT02384434)
NCT ID: NCT02384434
Last Updated: 2025-06-27
Results Overview
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
COMPLETED
NA
16 participants
Up to 12 months
2025-06-27
Participant Flow
Participant milestones
| Measure |
Low Level Laser Therapy
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Low Level Laser Therapy
n=16 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Age, Continuous
|
69.62 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Patients who received at least 1 dose of study treatment.
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
Outcome measures
| Measure |
Low Level Laser Therapy
n=9 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Grade 3 or Higher Adverse Events
|
9 Participants
|
SECONDARY outcome
Timeframe: At BaselinePopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=16 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
43.8 score on a scale
Standard Deviation 21.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
47.3 score on a scale
Standard Deviation 32.0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
28.1 score on a scale
Standard Deviation 25.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
40.6 score on a scale
Standard Deviation 27.2
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
35.9 score on a scale
Standard Deviation 30.2
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
48.4 score on a scale
Standard Deviation 34.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
35.9 score on a scale
Standard Deviation 22.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
21.3 score on a scale
Standard Deviation 24.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
21.2 score on a scale
Standard Deviation 30.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
15.0 score on a scale
Standard Deviation 15.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
30.0 score on a scale
Standard Deviation 29.0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
27.5 score on a scale
Standard Deviation 35.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
42.9 score on a scale
Standard Deviation 20.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
31.7 score on a scale
Standard Deviation 30.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Overall QOL
|
37.1 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Up to 4.5 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=15 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
54.4 score on a scale
Standard Deviation 12.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
44.1 score on a scale
Standard Deviation 29.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
35 score on a scale
Standard Deviation 19.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
44.4 score on a scale
Standard Deviation 34.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
44.7 score on a scale
Standard Deviation 28.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
49.4 score on a scale
Standard Deviation 26.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
49.4 score on a scale
Standard Deviation 20
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
51.8 score on a scale
Standard Deviation 25.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
20.3 score on a scale
Standard Deviation 29.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
27.3 score on a scale
Standard Deviation 29.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
41.6 score on a scale
Standard Deviation 29.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
79.8 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
55.3 score on a scale
Standard Deviation 18.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
51.4 score on a scale
Standard Deviation 19.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
50.7 score on a scale
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 4.5-7.5 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=8 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
43.8 score on a scale
Standard Deviation 17.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
47.1 score on a scale
Standard Deviation 21.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
25.0 score on a scale
Standard Deviation 18.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
32.1 score on a scale
Standard Deviation 31.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
35.7 score on a scale
Standard Deviation 24.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
34.4 score on a scale
Standard Deviation 26.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
39.3 score on a scale
Standard Deviation 19.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
48.6 score on a scale
Standard Deviation 28.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
30.7 score on a scale
Standard Deviation 29.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
8.6 score on a scale
Standard Deviation 14.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
31.4 score on a scale
Standard Deviation 33.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
52.9 score on a scale
Standard Deviation 21.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
51.4 score on a scale
Standard Deviation 10.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
28.6 score on a scale
Standard Deviation 26.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
42.9 score on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 7.5-10.5 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=7 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
46.4 score on a scale
Standard Deviation 22.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
37.9 score on a scale
Standard Deviation 24.8
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
21.4 score on a scale
Standard Deviation 18.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
25 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
50 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
30.4 score on a scale
Standard Deviation 26.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
41.1 score on a scale
Standard Deviation 23.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
28.6 score on a scale
Standard Deviation 31.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
14.3 score on a scale
Standard Deviation 27
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
18.6 score on a scale
Standard Deviation 26.7
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
15.7 score on a scale
Standard Deviation 15.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
49.3 score on a scale
Standard Deviation 28.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
46.7 score on a scale
Standard Deviation 15.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
16.7 score on a scale
Standard Deviation 21.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
45.0 score on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: 10.5-13.5 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
37.5 score on a scale
Standard Deviation 14.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
17.5 score on a scale
Standard Deviation 35.0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
12.5 score on a scale
Standard Deviation 14.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
12.5 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
18.8 score on a scale
Standard Deviation 12.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
28.1 score on a scale
Standard Deviation 32.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
43.8 score on a scale
Standard Deviation 12.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
25.0 score on a scale
Standard Deviation 33.2
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
30 score on a scale
Standard Deviation 35.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
3.8 score on a scale
Standard Deviation 7.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
15 score on a scale
Standard Deviation 17.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
27.5 score on a scale
Standard Deviation 20.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
42.5 score on a scale
Standard Deviation 5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
21.9 score on a scale
Standard Deviation 21.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
30 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: 13.5-16.5 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
46.9 score on a scale
Standard Deviation 29.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
12.5 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
6.2 score on a scale
Standard Deviation 12.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
12.5 score on a scale
Standard Deviation 25
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
18.8 score on a scale
Standard Deviation 23.9
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
0 score on a scale
Standard Deviation 0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
43.8 score on a scale
Standard Deviation 31.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
7.5 score on a scale
Standard Deviation 15.0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
17.5 score on a scale
Standard Deviation 35
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
7.5 score on a scale
Standard Deviation 15
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
25.0 score on a scale
Standard Deviation 33.2
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
22.5 score on a scale
Standard Deviation 15
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
45 score on a scale
Standard Deviation 10
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
50 score on a scale
Standard Deviation 20.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
35 score on a scale
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: after 16.5 months, up to 48.9 monthsPopulation: Treated patients who completed UW-QOL assessments.
The University of Washington Quality of Life Questionnaire (UW-QOL) consists of 12 single question domains focusing on patient health/quality of life within the past 7 days. Domains are scaled evenly from 0 (worst) to 100 (best) per the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety; patient choice of up to three of these domains that have been the most important to them. There are also three global questions, one about how the patient feel relative to before they developed their cancer, one about their health-related QOL and one about overall QOL. Patients are asked to consider not only physical \& mental health, but also many other factors, such as family, friends, spirituality or personal leisure activities that were important to their enjoyment of life in overall quality of life. Scores for each of the individual response options are summed to determine the domain score.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Activity
|
35.4 score on a scale
Standard Deviation 12.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Anxiety
|
21 score on a scale
Standard Deviation 31.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Appearance
|
11.6 score on a scale
Standard Deviation 13.5
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Chewing
|
16.7 score on a scale
Standard Deviation 23.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Mood
|
25.6 score on a scale
Standard Deviation 29.2
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Pain
|
17.6 score on a scale
Standard Deviation 32.8
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Recreation
|
40.8 score on a scale
Standard Deviation 16.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Saliva
|
15 score on a scale
Standard Deviation 17.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Shoulder
|
14 score on a scale
Standard Deviation 16.8
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Speech
|
2.5 score on a scale
Standard Deviation 5.0
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Swallowing
|
33.9 score on a scale
Standard Deviation 45.3
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Taste
|
19. score on a scale
Standard Deviation 9.6
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL last 7 days
|
46.8 score on a scale
Standard Deviation 10.4
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - QOL since 1 mo. before cancer
|
38.8 score on a scale
Standard Deviation 27.1
|
|
University of Washington Quality of Life Questionnaire (UW-QOL)
Global severity - Overall QOL
|
40.4 score on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=15 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
4.0 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
General Activity
|
6.3 score on a scale
Standard Deviation 2.6
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
5.8 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
Mood
|
5.0 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Normal Work
|
5.6 score on a scale
Standard Deviation 3.3
|
|
Brief Pain Inventory (BPI)
Relationships
|
4.3 score on a scale
Standard Deviation 3.7
|
|
Brief Pain Inventory (BPI)
Sleep
|
6.3 score on a scale
Standard Deviation 2.7
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
3.0 score on a scale
Standard Deviation 3.8
|
|
Brief Pain Inventory (BPI)
Average pain
|
5.5 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory (BPI)
Pain right now
|
4.8 score on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
7.1 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Up to 4.5 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=11 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
6.3 score on a scale
Standard Deviation 3.3
|
|
Brief Pain Inventory (BPI)
General Activity
|
5.5 score on a scale
Standard Deviation 2.6
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
5.1 score on a scale
Standard Deviation 3.4
|
|
Brief Pain Inventory (BPI)
Mood
|
5.2 score on a scale
Standard Deviation 3.4
|
|
Brief Pain Inventory (BPI)
Normal Work
|
3.7 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Relationships
|
3.6 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
Sleep
|
5.9 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
3.3 score on a scale
Standard Deviation 3.2
|
|
Brief Pain Inventory (BPI)
Average pain
|
5 score on a scale
Standard Deviation 2.7
|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
4.1 score on a scale
Standard Deviation 2.3
|
|
Brief Pain Inventory (BPI)
Pain right now
|
5.4 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 4.5-7.5 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=3 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
Sleep
|
4.3 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
General Activity
|
2.7 score on a scale
Standard Deviation 3.8
|
|
Brief Pain Inventory (BPI)
Mood
|
4.0 score on a scale
Standard Deviation 4.0
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
4.3 score on a scale
Standard Deviation 4.5
|
|
Brief Pain Inventory (BPI)
Normal Work
|
4.3 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Relationships
|
3.7 score on a scale
Standard Deviation 3.8
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
4.3 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
5.8 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Pain least in last week (N
|
3.5 score on a scale
Standard Deviation 3.4
|
|
Brief Pain Inventory (BPI)
Average pain
|
4.8 score on a scale
Standard Deviation 2.2
|
|
Brief Pain Inventory (BPI)
Pain right now
|
4.3 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 7.5-10.5 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
General Activity
|
3 score on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
5.2 score on a scale
Standard Deviation 1.7
|
|
Brief Pain Inventory (BPI)
Mood
|
2.6 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory (BPI)
Normal Work
|
2.5 score on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (BPI)
Relationships
|
0.8 score on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI)
Sleep
|
5.1 score on a scale
Standard Deviation 3
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
3.5 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Average pain
|
3.8 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
3.1 score on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (BPI)
Pain right now
|
3.9 score on a scale
Standard Deviation 3.4
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
4.8 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 10.5-13.5 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=2 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
General Activity
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
1.5 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory (BPI)
Mood
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Brief Pain Inventory (BPI)
Normal Work
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Brief Pain Inventory (BPI)
Relationships
|
0.0 score on a scale
Standard Deviation 0.0
|
|
Brief Pain Inventory (BPI)
Sleep
|
3.0 score on a scale
Standard Deviation 4.2
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
0.5 score on a scale
Standard Deviation 0.7
|
|
Brief Pain Inventory (BPI)
Average pain
|
3.5 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
3.0 score on a scale
Standard Deviation 4.2
|
|
Brief Pain Inventory (BPI)
Pain right now
|
3.0 score on a scale
Standard Deviation 4.2
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
4.0 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 13.5-16.5 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=2 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
Pain right now
|
5.0 score on a scale
Standard Deviation 7.1
|
|
Brief Pain Inventory (BPI)
General Activity
|
6.5 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
6.5 score on a scale
Standard Deviation 4.9
|
|
Brief Pain Inventory (BPI)
Mood
|
6.5 score on a scale
Standard Deviation 3.5
|
|
Brief Pain Inventory (BPI)
Normal Work
|
7.0 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
Relationships
|
4.5 score on a scale
Standard Deviation 4.9
|
|
Brief Pain Inventory (BPI)
Sleep
|
6.5 score on a scale
Standard Deviation 4.9
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
4.5 score on a scale
Standard Deviation 6.4
|
|
Brief Pain Inventory (BPI)
Average pain
|
4.5 score on a scale
Standard Deviation 4.9
|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
5.0 score on a scale
Standard Deviation 4.2
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
5.5 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: after 16.5 months, up to 48.9 monthsPopulation: Treated patients who completed BPI assessments.
Pain parameters assessed using Brief Pain Inventory (BPI). The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes (impact on) with common dimensions of feeling and function. No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items (Pain Worst in last week, Pain least in last week, Average Pain, Pain right now) indicates pain severity; the arithmetic mean of the seven interference items (General Activity, Mood, Walking Ability, Normal Work, Relationships, Sleep, Enjoyment of Life) measures how much pain impacted/interfered with a patient's various daily activities. Total scores range = 0 -10 for each item (mean of patient scores for each item). Pain and interference of pain in daily activities is scored as follows: 1 - 4 = Mild, 5 - 6 = Moderate, 7 - 10 = Severe Higher scores indicate greater pain and/or greater impact of pain and interference in activity, per item.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Brief Pain Inventory (BPI)
General Activity
|
2.2 score on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life
|
2 score on a scale
Standard Deviation 2.4
|
|
Brief Pain Inventory (BPI)
Mood
|
1.8 score on a scale
Standard Deviation 2.6
|
|
Brief Pain Inventory (BPI)
Normal Work
|
2.4 score on a scale
Standard Deviation 2.9
|
|
Brief Pain Inventory (BPI)
Relationships
|
1.2 score on a scale
Standard Deviation 1.5
|
|
Brief Pain Inventory (BPI)
Sleep
|
1.7 score on a scale
Standard Deviation 2.8
|
|
Brief Pain Inventory (BPI)
Walking Ability
|
2.5 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Average pain
|
2 score on a scale
Standard Deviation 2.6
|
|
Brief Pain Inventory (BPI)
Pain least in last week
|
1.5 score on a scale
Standard Deviation 2.1
|
|
Brief Pain Inventory (BPI)
Pain right now
|
1.7 score on a scale
Standard Deviation 3.1
|
|
Brief Pain Inventory (BPI)
Pain Worst in last week
|
2.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=15 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
4.1 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
3.7 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
4.1 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.3 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.3 score on a scale
Standard Deviation 1.0
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
4.2 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Dermatology Life Quality Index (DLQI)
Social
|
4.1 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
1.3 score on a scale
Standard Deviation 1.5
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.5 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Up to 4.5 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=14 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
3.3 score on a scale
Standard Deviation 1.2
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
3.2 score on a scale
Standard Deviation 0.9
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
3.2 score on a scale
Standard Deviation 1.0
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
3.4 score on a scale
Standard Deviation 0.7
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
2.6 score on a scale
Standard Deviation 0.9
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
3.7 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.0 score on a scale
Standard Deviation 0.9
|
|
Dermatology Life Quality Index (DLQI)
Social
|
3.3 score on a scale
Standard Deviation 1
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.2 score on a scale
Standard Deviation 1
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
0.6 score on a scale
Standard Deviation 0.9
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.7 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 4.5 - 7.5 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
3.5 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.0 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.5 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
4.5 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.0 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Social
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.2 score on a scale
Standard Deviation 1.0
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
0.8 score on a scale
Standard Deviation 1.5
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.8 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 7.5-10.5 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=8 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
3.9 score on a scale
Standard Deviation 0.4
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.1 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.3 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
3.9 score on a scale
Standard Deviation 0.9
|
|
Dermatology Life Quality Index (DLQI)
Social
|
3.9 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
3.5 score on a scale
Standard Deviation 1.3
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
2.4 score on a scale
Standard Deviation 1.1
|
|
Dermatology Life Quality Index (DLQI)
Working
|
1.9 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 10.5-13.5 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
4.0 score on a scale
Standard Deviation 0.0
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
4.0 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.0 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.5 score on a scale
Standard Deviation 1
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Social
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.4 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
1.9 score on a scale
Standard Deviation 1.4
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.4 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 13.5-16.5 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Social
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Activity
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
4.0 score on a scale
Standard Deviation 0.0
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
4.0 score on a scale
Standard Deviation 0.0
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.2 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
4.0 score on a scale
Standard Deviation 0.0
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.5 score on a scale
Standard Deviation 0.6
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.0 score on a scale
Standard Deviation 0.8
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
2.2 score on a scale
Standard Deviation 1.5
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.2 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: after 16.5 months, up to 48.9 monthsPopulation: Treated patients who completed DLQI assessments.
Dermatologic quality of life responses measured using the Dermatology Life Quality Index (DLQI). The DLQI is a ten-question questionnaire designed to measure the health-related quality of life of adult patients suffering from a skin disease, the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact on quality of life) to 30 (meaning maximum impact on quality of life). Scoring bands: 0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect. Higher scores indicate greater impact of skin disease on patient's life.
Outcome measures
| Measure |
Low Level Laser Therapy
n=4 Participants
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Dermatology Life Quality Index (DLQI)
Activity
|
3.8 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Appearance
|
4 score on a scale
Standard Deviation 0.1
|
|
Dermatology Life Quality Index (DLQI)
Clothes
|
4 score on a scale
Standard Deviation 0.1
|
|
Dermatology Life Quality Index (DLQI)
Messy
|
4.3 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Pain
|
3.5 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Problems
|
4 score on a scale
Standard Deviation 0.1
|
|
Dermatology Life Quality Index (DLQI)
Sexual
|
4.3 score on a scale
Standard Deviation 0.5
|
|
Dermatology Life Quality Index (DLQI)
Social
|
4 score on a scale
Standard Deviation 0.1
|
|
Dermatology Life Quality Index (DLQI)
Sport
|
4.1 score on a scale
Standard Deviation 0.1
|
|
Dermatology Life Quality Index (DLQI)
Studying
|
2.2 score on a scale
Standard Deviation 1.4
|
|
Dermatology Life Quality Index (DLQI)
Working
|
2.3 score on a scale
Standard Deviation 0.5
|
Adverse Events
Low Level Laser Therapy
Serious adverse events
| Measure |
Low Level Laser Therapy
n=16 participants at risk
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
18.8%
3/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
4/16 • Up to 5 years and 5.5 months for the study population.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
General disorders
Pain
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
Other adverse events
| Measure |
Low Level Laser Therapy
n=16 participants at risk
Non-invasive, cold laser output treatment.
THOR Laser System for Low Level Laser Therapy (LLLT): Non-invasive, a cold laser output treatment.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
50.0%
8/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Dry mouth
|
75.0%
12/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Dysphagia
|
75.0%
12/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
4/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Mucositis oral
|
62.5%
10/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • Up to 5 years and 5.5 months for the study population.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
General disorders
Fatigue
|
93.8%
15/16 • Up to 5 years and 5.5 months for the study population.
|
|
General disorders
Pain
|
93.8%
15/16 • Up to 5 years and 5.5 months for the study population.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
75.0%
12/16 • Up to 5 years and 5.5 months for the study population.
|
|
Investigations
Weight loss
|
25.0%
4/16 • Up to 5 years and 5.5 months for the study population.
|
|
Metabolism and nutrition disorders
Anorexia
|
68.8%
11/16 • Up to 5 years and 5.5 months for the study population.
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Up to 5 years and 5.5 months for the study population.
|
|
Nervous system disorders
Dysgeusia
|
68.8%
11/16 • Up to 5 years and 5.5 months for the study population.
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Up to 5 years and 5.5 months for the study population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Up to 5 years and 5.5 months for the study population.
|
|
Psychiatric disorders
Depression
|
18.8%
3/16 • Up to 5 years and 5.5 months for the study population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
5/16 • Up to 5 years and 5.5 months for the study population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • Up to 5 years and 5.5 months for the study population.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.0%
4/16 • Up to 5 years and 5.5 months for the study population.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
68.8%
11/16 • Up to 5 years and 5.5 months for the study population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16 • Up to 5 years and 5.5 months for the study population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place