Radiation Dermatitis
Conditions
Keywords
Radiation, dermatitis, radiodermatitis, radiotherapy induced, skin reactions, low level laser therapy, breast cancer
Brief summary
Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes. LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.
Interventions
DEVICELow-Level Laser Therapy
Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful
Sponsors
Hasselt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma * Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment * Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week) * Provide signed informed consent
Exclusion criteria
* Previous irradiation to the same breast * Metastatic disease * Mastectomy surgery * Concurrent chemo-radiotherapy * Required use of bolus material to deliver radiation therapy (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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dermatitis Assessment | 3 months (during radiation therapy and one month after) | Radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) |
| Pain | 3 months (during radiation therapy and one month after) | evaluation of pain using a visual analogue scale |
| Radiation Dermatitis Grade | 3 months (during radiation therapy and one month after) | 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 |
|---|---|---|
| Satisfaction with therapy | 3 months (during radiation therapy and one month after) | Self-report on the efficacy of and the global satisfaction with the management of radiation dermatitis |
| Quality of Life | 3 months (during radiation therapy and one month after) | Health-related quality of life measure specific to skin diseases (Skindex-16) |
| Impact of Radiation Dermatitis | 3 months (during radiation therapy and one month after) | Self-report on the impact of radiation dermatitis on daily activities |
Other
| Measure | Time frame | Description |
|---|---|---|
| Moist desquamation | 6.5 weeks (during radiation therapy) | Onset time of moist desquamation |
Countries
Belgium
Outcome results
None listed