Laser Therapy for the Management of Radiation Dermatitis

Study Overview
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Brief Summary
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Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes. LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.

Official Title
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Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: Low-Level Laser Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week) Provide signed informed consent Exclusion Criteria: Previous irradiation to the same breast Metastatic disease Mastectomy surgery Concurrent chemo-radiotherapy Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
Sexes Eligible for Study
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Female

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Receives institutional skin care protocol | |
| Experimental: Treatment Group<br>Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy | Device: Low-Level Laser Therapy<br>* Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful<br>|

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) | 
| Pain | evaluation of pain using a visual analogue scale | 3 months (during radiation therapy and one month after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Health-related quality of life measure specific to skin diseases (Skindex-16) | 3 months (during radiation therapy and one month after) | 
| Impact of Radiation Dermatitis | Self-report on the impact of radiation dermatitis on daily activities | 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 radiation dermatitis | 3 months (during radiation therapy and one month after) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer