Breast Cancer
Conditions
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.
Interventions
DEVICELow-level laser
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.
DEVICEsham laser
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.
RADIATIONradiotherapy
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze the skin cytokine content of the irradiated and non-irradiated breast | day 1 | Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA |
| Radiation Dermatitis Assessment | day 1 | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) |
| Objective measurement of trans epidermal water loss of the skin | day 1 | Tewa meter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin |
| Objective measurement of the skin hydration | day 1 | 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 1 | Mexa meter MX18 will be used to objectively measure the degree of erythema of the skin |
| Radiation Dermatitis Grade | day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | day 1 | Health-related quality of life measure specific to skin diseases |
| Satisfaction with therapy | day 1 | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis |
| moist desquamation | day 1 | 3 months (during radiotherapy + 1 month after radiotherapy) Description: Onset time of moist desquamation |
| Pain | day 1 | Evaluation of pain using a Visual Analogue Scale (VAS) |
Countries
Belgium
Outcome results
None listed