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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
139
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.
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.
Jessa Hospital - Oncology department
Hasselt, Belgium
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: day 54
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: day 1
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: day 20
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: day 33
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: day 40
Radiation Dermatitis Assessment
radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: day 54
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Time frame: day 1
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Time frame: day 20
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Time frame: day 33
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Time frame: day 40
Pain
Evaluation of pain using a Visual Analogue Scale (VAS)
Time frame: day 54
Quality of life
Health-related quality of life measure specific to skin diseases
Time frame: day 1
Quality of life
Health-related quality of life measure specific to skin diseases
Time frame: day 20
Quality of life
Health-related quality of life measure specific to skin diseases
Time frame: day 33
Quality of life
Health-related quality of life measure specific to skin diseases
Time frame: day 40
Quality of life
Health-related quality of life measure specific to skin diseases
Time frame: day 54
Satisfaction with therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time frame: day 1
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time frame: day 20
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time frame: day 33
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time frame: day 40
Satisfaction with therapy
Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
Time frame: day 54
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time frame: day 1
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time frame: day 20
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time frame: day 33
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time frame: day 40
moist desquamation
3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Time frame: day 54