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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) |
|
| Control group | Sham Comparator | Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-level laser | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, prof. dr. | Universiteit Hasselt/ Jessa ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital - Oncology department | Hasselt | 3500 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| sham laser | Device | 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. |
|
| radiotherapy | Radiation |
|
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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |