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Background The aim is to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute radiodermatitis (RD) in breast cancer patients undergoing radiotherapy (RT). Study Design/Materials and Method This randomized, placebo-controlled trial enrolled 66 breast cancer patients that underwent an identical RT regime post-lumpectomy. Patients were randomly assigned to the laser (n=34) or placebo group (n=32). There were no significant differences between the two groups with respect to patient- and treatment-related characteristics. Laser or placebo was applied two days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLS® M6 laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2). Clinical scoring of RD (Radiation Therapy Oncology Group (RTOG) grading scale) and biophysical measurements (skin hydration, transepidermal water loss (TEWL), and degree of erythema) were determined at the first day, at fraction 20 and at the end of RT. In the results section, only preliminary results of the RTOG scores are shown. Results At fraction 20 of RT, there was no significant difference between the groups in the distribution of RTOG grades (p= .524), with most of the patients presenting RTOG grade 1. Towards the end of RT, the skin reactions worsened in the placebo group (p= 0.016), while they remained stable in the laser group (p= .207). There was a significant difference in the severity of RD between the two groups (p= .021) with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g. moist desquamation) in the placebo group (28.1% vs. 5.9%, for the placebo and laser group, resp.) at the last day of RT. Conclusion The preliminary results of this first randomized, placebo-controlled trial show that PBMT can prevent aggravation of acute RD in breast cancer patients. LCRP; Limburgs Kankerfonds; ASA srl

Photobiomodulation therapy is based on the application of visible and/or (near-)infrared light on the target tissue. We performed a review of 34 articles on the use of photobiomodulation therapy in the management of cancer related lymphoedema, oral mucositis, radiodermatitis, chemotherapy-induced peripheral neuropathy, osteonecrosis of the jaw, and xerostomia/hyposalivation. The findings suggest that photobiomodulation therapy is a promising option for the management of these cancer therapy-related side effects. This study is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg and Jessa Hospital. Additionally, this research is supported by the foundations Limburgs Kankerfonds, Kom op Tegen Kanker and ASA srl.

Introduction: We investigated patients with contemporarily staged and treated stage III-N2 NSCLC treated with induction chemotherapy and surgery with or without postoperative radiotherapy (PORT). We focused on survival and toxicity and investigated what additional PORT may offer in patients with ypN2 status or incomplete resection. Methods: We identified 161 patients with pathologically proven, resectable stage III-N2 NSCLC from our prospective database who were treated between 1998 and 2012. Of these patients, 150 without progressive disease after chemotherapy underwent resection. Patients with ypN2 status or R1/2 resection received three-dimensional PORT (n = 70) to a dose of 50 to 66 Gy in 2-Gy fractions. Results: The mean follow-up time was 49 months. The 5-year overall survival (OS) rate was 35.1% in intention to -treat analysis; relapse-free survival was 31.8%, the cumulative local recurrence (LR) rate was 50.9%, and the distant metastasis rate was 63.4%. The 5-year OS, relapse free survival, and cumulative LR and distant metastasis rates were 32.0%, 32.9%, 47.0%, and 63.9% in the PORT group versus 38.1%, 30.7%, 54.1%, and 63.2% in the non-PORT group. These results were not significantly different, even though patients in the PORT group had worse prognostic features. Cardiac toxicity was higher in the non PORT group (p = 0.02), but pulmonary toxicity was similar (p = 0.15). There Was no difference between the two groups regarding dyspnea (p = 0.32), cough (p = 0.37), forced expiratory volume in 1 second (p = 0.30), and diffusing capacity of the lung for carbon monoxide (p = 0.61). Conclusions: A similar outcome (OS, LR, and toxicity) was seen in both patient groups (PORT versus non-PORT group). Despite the limitations of this retrospective study, PORT can be both effective and safe for patients with stage III-N2 NSCLC with an R1/R2 resection or yN2 after induction chemotherapy and surgery. (C) 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved. This study is part of the Limburg Clinical Research Program UHasselt-ZOL-Jessa, which is supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University: Ziekenhuis Oost-Limburg, and Jessa Hospital. Charlotte Billiet is supported by the Cancer Foundation Limburg.

Rationale, aims, and objectives The systematic assessment of cancer patients well-being and care needs is internationally recommended to optimize comprehensive cancer care. The Cancer Rehabilitation Evaluation System (CARES) is a psychometrically robust quality of life and needs assessment tool of US origin, developed in the early 1990s. This article describes Belgian patients' view on the content validity and feasibility of the CARES for use in current cancer care. Methods Participants were cancer patients recruited through media. Data were gathered in 4 focus groups (n = 26). The focus group discussions were facilitated with key questions. A moderator and an observer conducted and followed up the discussion. The audio file was transcribed verbatim and afterwards analyzed thematically. Results Participants experience concerns and needs in a wide range of life domains such as physical, emotional, cognitive, social, relational, sexual, financial, and work-related and in the interaction with care professionals. According to participants, the items of the CARES are all relevant to capture the possible life disruption that cancer patients and survivors experience. One important theme is missing in the CARES, namely, the well-being of loved ones. The completion time of the CARES was judged to be feasible, and according to participants, only a few items need a reformulation. Conclusions In general, the results of this study support the content validity and feasibility of the CARES. However, little adjustments in formulation and a few extra items are needed. The instrument can be used to obtain a comprehensive assessment of a cancer patients' overall well-being and care needs to take dedicated action in care. Our gratitude goes out to the team of Huis Erika Thijs for their hospitality and for the provision of facilities during the FGs. We would like to thank Willem van de Esschert for his practical support in conducting the FGs, Noemie Aubert Bonn for editing the manuscript for the English language, and Limburg Sterk Merk (L.S.M.) for funding the PhD-research project of Bojoura Schouten.

Introduction:About 90 to 95% of the patients undergoing radiotherapy (RT) as part of their cancer treatment develop acute radiodermatitis (ARD), an inflammatory skin reaction. Previous studies demonstrated that photobiomodulation therapy (PBMT) is effective in managing ARD in breast cancer patients. The aim of this study was to investigate the effectiveness of PBMT in the prevention of ARD in head and neck cancer (HNC) patients.Methods:A prospective, single blind, multicentric, clinical trial was set up at the radiotherapy department of the Jessa Hospital (Hasselt, Belgium) and Ziekenhuis Oost-Limburg (Genk, Belgium). HNC patients planned to undergo RT with or without concomitant chemotherapy (i.e. stratification factor) were randomized into the placebo or PBMT group. Sham or PBM treatments were applied twice weekly during the complete RT course. An experienced nurse evaluated the skin reactions at baseline, at a dose of 40 Gy, and at the end RT (60-70 Gy) by using the Radiation Therapy Oncology Group (RTOG) criteria.Results:For this preliminary analysis (February 2019), data of 37 patients was available. The percentage of HNC patients presenting a RTOG grade u2265 2 was significantly higher in the placebo in comparison with the PBMT group at the end of RT (70,6% vs. 25%, resp.; p=0.01). Moreover, the results indicated that the skin toxicity aggravated in the placebo group (p=0.03), while it remained stable in the PBMT group towards the final RT session (p=0.47). Conclusions:This is the first, placebo-controlled, multicentric trial demonstrating the positive effect of PBMT for the prevention of ARD in HNC patients.

Factor solutions exploring CARES subscales. (DOC 167Â kb)

CARES Patient profile. (PDF 173Â kb)

Summary of needs assessment tools and psychometric properties. The table in this file displays a summary of 24 needs assessment tools and their psychometric properties. Items, domains, validity (content validity and other types of validity), reliability (internal consistency and reproducibility), responsiveness and feasibility are discussed. (DOCX 44Â kb)

CARES Validity Ratings. (DOC 45Â kb)

CARES Questionnaire. (PDF 7917Â kb)

Objectives: The evidence demonstrating the efcacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the diseasefree survival (DFS), cancerfree survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD. Methods: Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808−905 nm, 4 J/cm 2) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During followup (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the rst 5 years after the end of RT. The DFS, CFS, and OS were estimated. Results: At a median followup time of 66 months (range 4−81), there was no signicant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group. Conclusions: This paper is the rst to describe the results of a longterm followup in earlystage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not inuence the locoregional recurrence, the development of new primary tumors, or OS. We would like to thank all patients, doctors, and nurses for their participation in TRANSDERMIS trial. In addition, we want to thank Jessa Hospital and Hasselt University for providing the needed infrastructure and software packages. This study is part of the Limburg Clinical Research Center (LCRC)UHasselt‐ZOL‐Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost‐Limburg, and Jessa Hospital. Additionally, this study is supported by Kom op Tegen Kanker (Stand up to Cancer), the Flemish cancer society, LimburgsKankerfonds, and ASA Srl.

Background and purpose The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methods A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. Results PBMT significantly reduced NCI-CTCAE grade 2–3 ARD with 49% at the end of RT. Conclusion The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology – radiotherapy practice. This research is part of the Limburg Clinical Research Center (LCRC) UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish Government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Additionally, this research project is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl.