Radiation DermatitisNCT02384434
Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
A study testing THOR Laser System for Low Level Laser Therapy (LLLT) in people with Radiation Dermatitis, run by Heath Skinner at 1 site in United States.
Trial summary
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- THOR Laser System for Low Level Laser Therapy (LLLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2015to 13 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age
- Karnofsky performance status > 70
- Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- No prior radiotherapy to the head and neck region.
- No previous systemic chemotherapy or targeted therapy
- Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- Patients using standard therapies for cetuximab-induced acne-form rash will be included.
Who cannot join
- Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
- Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- Concurrent serious infection
- Continued use of Niacin
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center - Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
Read the detailed description
This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy.
Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy.
Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.
- Conditions
- Radiation Dermatitis
- Being tested
- THOR Laser System for Low Level Laser Therapy (LLLT)
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR Laser System for Low Level Laser Therapy (LLLT)Device
Non-invasive, a cold laser output treatment.
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy | Other | Non-invasive, cold laser output treatment. Receives: Device: THOR Laser System for Low Level Laser Therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or Higher Adverse Events
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
Measured: Up to 12 months
Secondary outcomes (21)
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: At Baseline
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: Up to 4.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: 4.5-7.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: 7.5-10.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: 10.5-13.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: 13.5-16.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
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.
Measured: after 16.5 months, up to 48.9 months
Brief Pain Inventory (BPI)
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.
Measured: Baseline
Brief Pain Inventory (BPI)
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.
Measured: Up to 4.5 months
Brief Pain Inventory (BPI)
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.
Measured: 4.5-7.5 months
Brief Pain Inventory (BPI)
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.
Measured: 7.5-10.5 months
Brief Pain Inventory (BPI)
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.
Measured: 10.5-13.5 months
Brief Pain Inventory (BPI)
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.
Measured: 13.5-16.5 months
Brief Pain Inventory (BPI)
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.
Measured: after 16.5 months, up to 48.9 months
Dermatology Life Quality Index (DLQI)
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.
Measured: Baseline
Dermatology Life Quality Index (DLQI)
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.
Measured: Up to 4.5 months
Dermatology Life Quality Index (DLQI)
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.
Measured: 4.5 - 7.5 months
Dermatology Life Quality Index (DLQI)
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.
Measured: 7.5-10.5 months
Dermatology Life Quality Index (DLQI)
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.
Measured: 10.5-13.5 months
Dermatology Life Quality Index (DLQI)
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.
Measured: 13.5-16.5 months
Dermatology Life Quality Index (DLQI)
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.
Measured: after 16.5 months, up to 48.9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start27 Apr 2015
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heath Skinner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heath Skinner, University of Pittsburgh
- Investigators
- Heath Skinner, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384434
- Sponsor's protocol ID
- HCC 18-128
- Status last verified
- Jun 2025
- First submitted
- 26 Feb 2015
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02384434
- Acronym / sponsor ID
- HCC 18-128
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Heath SkinnerUniversity, hospital or other
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.
Detailed description
This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy.
Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy.
Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Other | Device: THOR Laser System for Low Level Laser Therapy (LLLT)Non-invasive, cold laser output treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients ≥ 18 years of age
- Karnofsky performance status > 70
- Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- No prior radiotherapy to the head and neck region.
- No previous systemic chemotherapy or targeted therapy
Key exclusion criteria (4 listed)
- Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
- Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
- Concurrent serious infection
- Continued use of Niacin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR Laser System for Low Level Laser Therapy (LLLT)Non-invasive, a cold laser output treatment. | Device | Low Level Laser Therapy |
Primary outcome
Grade 3 or Higher Adverse Events
Time frame: Up to 12 months
Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.
21 secondary outcomes
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: At Baseline
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: Up to 4.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: 4.5-7.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: 7.5-10.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: 10.5-13.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: 13.5-16.5 months
University of Washington Quality of Life Questionnaire (UW-QOL)
Time frame: after 16.5 months, up to 48.9 months
Brief Pain Inventory (BPI)
Time frame: Baseline
Brief Pain Inventory (BPI)
Time frame: Up to 4.5 months
Brief Pain Inventory (BPI)
Time frame: 4.5-7.5 months
Brief Pain Inventory (BPI)
Time frame: 7.5-10.5 months
Brief Pain Inventory (BPI)
Time frame: 10.5-13.5 months
Brief Pain Inventory (BPI)
Time frame: 13.5-16.5 months
Brief Pain Inventory (BPI)
Time frame: after 16.5 months, up to 48.9 months
Dermatology Life Quality Index (DLQI)
Time frame: Baseline
Dermatology Life Quality Index (DLQI)
Time frame: Up to 4.5 months
Dermatology Life Quality Index (DLQI)
Time frame: 4.5 - 7.5 months
Dermatology Life Quality Index (DLQI)
Time frame: 7.5-10.5 months
Dermatology Life Quality Index (DLQI)
Time frame: 10.5-13.5 months
Dermatology Life Quality Index (DLQI)
Time frame: 13.5-16.5 months
Dermatology Life Quality Index (DLQI)
Time frame: after 16.5 months, up to 48.9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Head and Neck Neoplasms, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heath Skinner, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR Laser System for Low Level Laser Therapy (LLLT) in people with Radiation Dermatitis, run by Heath Skinner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or Higher Adverse Events (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.