Laser Therapy for the Prevention of Radiodermatitis in Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Device: sham laserDevice: Low-level laserRadiation: radiotherapy
- Registration Number
- NCT02443493
- Lead Sponsor
- Hasselt University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 139
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group radiotherapy Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) Control group radiotherapy Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) Control group sham laser Control group (receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy) Treatment group Low-level laser Treatment group (receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy)
- Primary Outcome Measures
Name Time Method Radiation Dermatitis Grade day 54 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)
Radiation Dermatitis Assessment day 54 radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of the skin hydration day 40 Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Objective measurement of degree of erythema of the skin day 54 Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin
Objective measurement of trans epidermal water loss of the skin day 54 Corneo meter CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Analyze the skin cytokine content of the irradiated and non-irradiated breast day 54 Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
- Secondary Outcome Measures
Name Time Method Satisfaction with therapy day 54 Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis
moist desquamation day 54 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation
Pain day 54 Evaluation of pain using a Visual Analogue Scale (VAS)
Quality of life day 54 Health-related quality of life measure specific to skin diseases
Trial Locations
- Locations (1)
Jessa Hospital - Oncology department
🇧🇪Hasselt, Belgium