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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Receives institutional skin care protocol | |
| Treatment Group | Experimental | Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy |
|
| 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 moment skin reactions become painful until skin reactions are no longer painful |
|
| 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) |
| Pain | evaluation of pain using a visual analogue scale | 3 months (during radiation therapy and one month after) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Health-related quality of life measure specific to skin diseases (Skindex-16) | 3 months (during radiation therapy and one month after) |
| Impact of Radiation Dermatitis | Self-report on the impact of radiation dermatitis on daily activities |
| Measure | Description | Time Frame |
|---|---|---|
| Moist desquamation | Onset time of moist desquamation | 6.5 weeks (during radiation therapy) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Mebis, MD, PhD | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital - Oncology department | Hasselt | B-3500 | Belgium |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D003872 | Dermatitis |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 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 radiation dermatitis | 3 months (during radiation therapy and one month after) |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |