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Completed

NCT Number: NCT02384434

Low Level Laser Therapy for Radiation Induced Dermatitis in H & N 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.

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Key information

Conditions

Radiation Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

THOR Laser System for Low Level Laser Therapy (LLLT)

Device

Non-invasive, a cold laser output treatment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: At Baseline

    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.

  2. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: Up to 4.5 months

    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.

  3. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: 4.5-7.5 months

    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.

  4. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: 7.5-10.5 months

    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.

  5. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: 10.5-13.5 months

    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.

  6. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: 13.5-16.5 months

    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.

  7. University of Washington Quality of Life Questionnaire (UW-QOL)

    Time frame: after 16.5 months, up to 48.9 months

    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.

  8. Brief Pain Inventory (BPI)

    Time frame: Baseline

    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.

  9. Brief Pain Inventory (BPI)

    Time frame: Up to 4.5 months

    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.

  10. Brief Pain Inventory (BPI)

    Time frame: 4.5-7.5 months

    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.

  11. Brief Pain Inventory (BPI)

    Time frame: 7.5-10.5 months

    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.

  12. Brief Pain Inventory (BPI)

    Time frame: 10.5-13.5 months

    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.

  13. Brief Pain Inventory (BPI)

    Time frame: 13.5-16.5 months

    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.

  14. Brief Pain Inventory (BPI)

    Time frame: after 16.5 months, up to 48.9 months

    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.

  15. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline

    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.

  16. Dermatology Life Quality Index (DLQI)

    Time frame: Up to 4.5 months

    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.

  17. Dermatology Life Quality Index (DLQI)

    Time frame: 4.5 - 7.5 months

    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.

  18. Dermatology Life Quality Index (DLQI)

    Time frame: 7.5-10.5 months

    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.

  19. Dermatology Life Quality Index (DLQI)

    Time frame: 10.5-13.5 months

    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.

  20. Dermatology Life Quality Index (DLQI)

    Time frame: 13.5-16.5 months

    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.

  21. Dermatology Life Quality Index (DLQI)

    Time frame: after 16.5 months, up to 48.9 months

    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.

Sponsors and collaborators

Lead sponsor

Heath Skinner

Other

Registry information

Official study title

Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2015
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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