Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome. Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation. Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT. The results of this project will support the implementation of PBMT into the standard RD skincare program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
71
PBMT sessions will be planned 2x/week after RT.
Sham laser sessions will be applied 2x/week after RT.
Ziekenhuis Oost-Limburg Campus St.-Jan
Genk, Limburg, Belgium
Jessa Ziekenhuis
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) 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: week 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) 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: week 2
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) 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: week 3
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) 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: week 4
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) 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: week 5
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) 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: week 6
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Time frame: week 1
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Time frame: week 2
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Time frame: week 3
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0-4)
Time frame: week 4
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS 0- 4)
Time frame: week 5
Radiation Dermatitis Assessment
Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS (0 - 4)
Time frame: week 6
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Time frame: week 1
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Time frame: week 2
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Time frame: week 3
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Time frame: week 4
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
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Time frame: week 5
Pain evaluation: VAS
Patients' pain due to radiodermatitis will be evaluated using the visual analogue scale (VAS 0-10). A VAS is a laminated plastic with descriptors at each end. The patients will be asked to move the sliding marker along the plastic to indicate their subjective experience of pain. Each mark is associated with a certain pain score. A VAS is a well documented, valid, and frequently used measure of pain intensity.
Time frame: week 6
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 1
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 2
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 3
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 4
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 5
Quality of life assessment
The Skindex-16 questionnaire will be used to assess patients quality of life. This is the most appropriate questionnaire that accurately and sensitively measures to what extent the patients' life is affected by their skin condition.
Time frame: week 6