Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer 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 pilot 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 pilot study 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 breast cancer patients.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Low-level laser
* Device: sham laser
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e. 25 daily fractions of 2 Gray to the whole breast followed by a boost of 8 fractions of 2 Gray to the tumor bed, 5/week) Signed informed consent Exclusion Criteria: Previous irradiation to the same breast Metastatic disease Concurrent chemotherapy Required use of bolus material to deliver radiotherapy (i.e. material placed on the to- be-irradiated zone to modulate the delivered dose in order the ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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<br>* Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.<br>* Other names: LLLT;Radiation: radiotherapy<br> <br> |
| 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>* Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.<br>Radiation: radiotherapy<br> <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) | day 1 | 
| 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) | day 20 | 
| 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) | day 33 | 
| 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) | day 40 | 
| 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) | day 54 | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | day 1 | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | day 20 | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | day 33 | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | day 40 | 
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | day 54 | 
| Objective measurement of trans epidermal water loss of the skin | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | day 1 | 
| Objective measurement of trans epidermal water loss of the skin | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | day 20 | 
| Objective measurement of trans epidermal water loss of the skin | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | day 33 | 
| Objective measurement of trans epidermal water loss of the skin | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | day 40 | 
| Objective measurement of trans epidermal water loss of the skin | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | day 54 | 
| Objective measurement of the skin hydration | Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | day 1 | 
| Objective measurement of the skin hydration | Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | day 20 | 
| Objective measurement of the skin hydration | Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | day 33 | 
| Objective measurement of the skin hydration | Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | day 40 | 
| Objective measurement of trans epidermal water loss of the skin | Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | day 54 | 
| Objective measurement of degree of erythema of the skin | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin | day 1 | 
| Objective measurement of degree of erythema of the skin | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin | day 20 | 
| Objective measurement of degree of erythema of the skin | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin | day 33 | 
| Objective measurement of degree of erythema of the skin | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin | day 40 | 
| Objective measurement of degree of erythema of the skin | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin | day 54 | 
| 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 | day 1 | 
| 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 | day 20 | 
| 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 | day 33 | 
| 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 | day 40 | 
| 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 | day 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Evaluation of pain using a Visual Analogue Scale (VAS) | day 1 | 
| Pain | Evaluation of pain using a Visual Analogue Scale (VAS) | day 20 | 
| Pain | Evaluation of pain using a Visual Analogue Scale (VAS) | day 33 | 
| Pain | Evaluation of pain using a Visual Analogue Scale (VAS) | day 40 | 
| Pain | Evaluation of pain using a Visual Analogue Scale (VAS) | day 54 | 
| Quality of life | Health-related quality of life measure specific to skin diseases | day 1 | 
| Quality of life | Health-related quality of life measure specific to skin diseases | day 20 | 
| Quality of life | Health-related quality of life measure specific to skin diseases | day 33 | 
| Quality of life | Health-related quality of life measure specific to skin diseases | day 40 | 
| Quality of life | Health-related quality of life measure specific to skin diseases | day 54 | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | day 1 | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | day 20 | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | day 33 | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | day 40 | 
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | day 54 | 
| moist desquamation | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation | day 1 | 
| moist desquamation | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation | day 20 | 
| moist desquamation | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation | day 33 | 
| moist desquamation | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation | day 40 | 
| moist desquamation | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation | day 54 |