Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients

Study Overview
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Brief Summary
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Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD). Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.

Official Title
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Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients

Conditions
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Head Cancer, Neck Cancer

Intervention / Treatment
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* Device: Low-level laser therapy
* Device: sham laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx Scheduled for radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either as primary or as post-operative treatment to the head and neck region Age ≥ 18 years Able to comply to the study protocol Able to sign written informed consent Signed written informed consent Exclusion Criteria: Previous irradiation to the head and/or neck region Metastatic disease Patients with pre-existing skin rash, ulceration or open wound in the treatment area Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator Patients using high doses of non-steroidal anti-inflammatory drugs
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy | Device: sham laser<br> <br> |
| Experimental: Treatment Group<br>Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy | Device: Low-level laser therapy<br>* Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.<br>* Other names: LLLT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Dermatitis Grade | objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) | 3 months (during radiation therapy and one month after) | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | 3 months (during radiation therapy and one month after) | 
| Objective measurement of trans epidermal water loss of the skin | Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | 3 months (during radiation therapy and one month after) | 
| Objective measurement of the skin hydration | Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | 3 months (during radiation therapy and one month after) | 
| Objective measurement of degree of erythema of the skin | Mexameter MX18 will be used to objectively measure the degree of erythema of the skin | 3 months (during radiation therapy and one month after) | 
| Analyze the skin cytokine content of the irradiated and non-irradiated breast | Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA | 3 months (during radiation therapy and one month after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-score | Evaluation of pain using a visual analogue scale (VAS) | 3 months (during radiation therapy and one month after) | 
| Skin dex 16 | Health-related quality of life measure specific to skin diseases (Skindex-16) | 3 months (during radiation therapy and one month after) | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | 3 months (during radiation therapy and one month after) | 
| moist desquamation | Onset time of moist desquamation | 3 months (during radiation therapy and one month after) |