Radiodermatitis, Breast Cancer
Conditions
Keywords
Radiodermatitis, Breast cancer, Radiotherapy, Photobiomodulation therapy, Low-level light therapy, Skin diseases, Radiation injuries, Wounds and injuries, Oncology
Brief summary
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.
Interventions
PBMT sessions will be planned 2x/week after RT.
DEVICESham laser
Sham laser sessions will be applied 2x/week after RT.
Sponsors
Jessa Hospital
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature * 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 at Ziekenhuis Oost-Limburg, Genk: * Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)
Exclusion criteria
* Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium * 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 to ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors) * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psyschological disorders, dementia, etc. of the participant * Seizure * Disorders triggered by lighttake anticoagulants * Hemorrhagic diatheses * Pregnancy * Suspected of carrying serious infectious disease * HIV positive history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dermatitis Grade | week 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) 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 | week 1 | Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation: VAS | week 1 | 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. |
| Quality of life assessment | week 1 | 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. |
Countries
Belgium
Outcome results
None listed