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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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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 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 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 head and neck cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
|
| Treatment Group | Experimental | Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-level laser therapy | Device | Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months (during radiation therapy and one month after) |
| Radiation Dermatitis Assessment | radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS) | 3 months (during radiation therapy and one month after) |
| Objective measurement of trans epidermal water loss of the skin | Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin | 3 months (during radiation therapy and one month after) |
| Objective measurement of the skin hydration | Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration | 3 months (during radiation therapy and one month after) |
| Objective measurement of degree of erythema of the skin | Mexameter MX18 will be used to objectively measure the degree of erythema of the skin | 3 months (during radiation therapy and one month after) |
| Analyze the skin cytokine content of the irradiated and non-irradiated breast | Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA | 3 months (during radiation therapy and one month after) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS-score | Evaluation of pain using a visual analogue scale (VAS) | 3 months (during radiation therapy and one month after) |
| Skin dex 16 | Health-related quality of life measure specific to skin diseases (Skindex-16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium | |||
| Jessa Ziekenhuis |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| sham laser | Device |
|
| 3 months (during radiation therapy and one month after) |
| Satisfaction with therapy | Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis | 3 months (during radiation therapy and one month after) |
| moist desquamation | Onset time of moist desquamation | 3 months (during radiation therapy and one month after) |
| Hasselt |
| 3500 |
| Belgium |