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Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy — LABRA  

Breast Cancer Clinical Trial

Official title:
The Use of Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients: a Multicentre, Randomized, Placebo-controlled Trial

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03924011
Study type Interventional
Source Hasselt University
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date June 1, 2021
View Details
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