The use of photobiomodulation therapy for the management of chemotherapy-induced alopecia: a randomized, controlled trial (HAIRLASER trial).

PURPOSE: The purpose of this trial was to evaluate if photobiomodulation (PBM) can accelerate hair regrowth after chemotherapy in breast cancer patients and if this is correlated with a better quality of life (QoL). METHODS: A randomized controlled trial with breast cancer patients that underwent an anthracycline and taxane-containing chemotherapy regimen was set up at the Jessa Hospital (Hasselt, Belgium). Patients were randomized into the control group (no intervention) or the PBM group (three PBM sessions each week for 12 weeks, starting the last day of their chemotherapy). Hair regrowth was evaluated based on photographic assessments. Two blinded researchers independently scored the hair regrowth using a numerical rating scale (NRS). In addition, the QoL was measured using the European Organization for Research and Treatment-QOL questionnaire and Breast Cancer-specific module (EORTC QLQ-C30 and QLQ-BR23). Data were collected on the day of their last chemotherapy session and 1, 2, and 3 months post-chemotherapy. RESULTS: A total of 32 breast cancer patients were included in the trial between June 2020 and February 2022. Significantly higher NRS scores were observed in the PBM group at 1-month post-chemotherapy compared to baseline, whereas they remained constant in the control group. Patients allocated to the PBM group scored their global health significantly higher at all time points compared to the control. CONCLUSION: Based on the results of the HAIRLASER trial, PBM seems to accelerate hair regrowth after chemotherapy in breast cancer patients resulting in an improved global health status and better body image. The study was registered in July 2019 at ClinicalTrials.gov (NCT04036994).

Photobiomodulation therapy for the prevention of acute radiation dermatitis in breast cancer patients undergoing hypofractioned whole-breast irradiation (LABRA trial).

OBJECTIVES: To evaluate the efficacy of photobiomodulation therapy in breast cancer patients post-lumpectomy undergoing hypofractionated whole-breast irradiation (HF-WBI) for the prevention and management of acute radiodermatitis (ARD). MATERIALS AND METHODS: A randomized, multicentric clinical trial (LABRA trial, NCT03924011) was set up at the Limburg Oncology Center, including the Jessa Hospital (Hasselt, BE) and Ziekenhuis Oost-Limburg (Genk, BE). A total of 71 breast cancer patients planned to undergo HF-WBI were randomized to one of the two study arms: the control group (n = 32) or the PBM group (n = 39). The PBM group received the standard institutional skincare combined with PBM (2×/week) during the complete radiotherapy (RT) course. Patients in the control group received the standard skincare combined with placebo treatment (2x/week). Patients' skin reactions were evaluated weekly during the RT treatment by using the modified version of the Radiation Therapy Oncology Group (RTOG) criteria. RESULTS: At week 3 of RT, one patient presented a grade 2 and one patient a grade 3 skin reaction in the control group, while in the PBM group, all patients still presented grade 1 ARD. At the final RT session 28% of the patients presenting grade 2-3 ARD, while in the PBM group 10% presented grade 2 and no grade 3 ARD. PBM reduced the incidence of severe ARD by 18%. However, the difference was not significant (p = 0.053). CONCLUSION: Based on the LABRA trial results, PBM seems not able to reduce the incidence of severe ARD in breast cancer patients undergoing HF-WBI. Research in a larger patient population is recommended.

Photobiomodulation therapy for the prevention of acute radiation dermatitis in head and neck cancer patients (DERMISHEAD trial).

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.

Safety and efficacy of photobiomodulation therapy in oncology: A systematic review.

We performed a systematic review of the current literature addressing the safety and efficacy of photobiomodulation therapy (PBMT) in cancer patients. In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. In vitro, in vivo, and clinical studies, which investigated the effect of PBMT on cell proliferation/differentiation, tumor growth, recurrence rate, and/or overall survival were included. The Medline/PubMed, EMBASE, and Scopus databases were searched through April 2020. A total of 67 studies met the inclusion criteria with 43 in vitro, 15 in vivo, and 9 clinical studies identified. In vitro studies investigating the effect of PBMT on a diverse range of cancer cell lines demonstrated conflicting results. This could be due to the differences in used parameters and the frequency of PBM applications. In vivo studies and clinical trials with a follow-up period demonstrated that PBMT is safe with regards to tumor growth and patient advantage in the prevention and treatment of specific cancer therapy-related complications. Current human studies, supported by most animal studies, show safety with PBMT using currently recommended clinical parameters, including in Head & Neck cancer (HNC) in the area of PBMT exposure. A significant and growing literature indicates that PBMT is safe and effective, and may even offer a benefit in patient overall survival. Nevertheless, continuing research is indicated to improve understanding and provide further elucidation of remaining questions regarding PBM use in oncology.

A Narrative Review on the Use of Photobiomodulation Therapy for the Prevention and Management of Acute Radiodermatitis: Proposed Mechanisms, Current Clinical Outcomes, and Preliminary Guidance for Clinical Studies.

Objective: A narrative review of the available scientific evidence to identify the current proposals relating the use of photobiomodulation (PBM) to treat acute radiodermatitis (ARD), to guide future research. Background data: A devastating side effect of radiotherapy (RT) is ARD, defined as an inflammatory skin reaction induced by RT. Currently, there is still no standard of care for ARD. PBM is a non-invasive light therapy that is a growing modality in the field of supportive cancer care. There is a need for identifying the therapeutic irradiation windows in this field, based on the available literature. Methods: An electronic search of original articles in the PubMed database was performed with the following keywords: "photobiomodulation therapy," "low-level light therapy," "low-level laser therapy," "acute radiodermatitis," and "radiotherapy" until December 2019. Randomized controlled trials, prospective non-randomized, case report, cohort, cross-over, and retrospective studies were selected for this review. Results: Nine clinical trials that investigated the use of photobiomodulation therapy (PBMT) in ARD were available for evaluation. Results demonstrate that PBMT could significantly reduce the severity of ARD and the accompanying discomfort and pain in patients with cancer. Conclusions: Based on the available evidence of the narrative review, PBM might be an effective therapy for the prevention and management of ARD in patients with cancer. More research is needed to confirm this finding.

Photobiomodulation Therapy for the Management of Chemotherapy-Induced Peripheral Neuropathy: An Overview.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy (CT), affecting 68% of patients. Current treatment strategies are based on pharmacological symptom management, but have limited results. Photobiomodulation therapy (PBMT) is a new and emerging therapeutic tool in the supportive care of cancer patients. In this overview, we explore the usability of PBMT for management of CIPN. Objective: To provide a comprehensive overview of management of CIPN with PBMT. Methods: Specific terms, including "Photobiomodulation Therapy," "Drug Therapy," and "Peripheral Nervous System Diseases," were identified for the literature research in PubMed. Results: Three articles were considered eligible for this review. Primary outcome measures were highly variable across the included studies. Conclusions: PBMT might be an effective treatment strategy to manage CIPN, with very encouraging reports from renowned teams, but evidence is limited. More methodologically uniform research (mainly regarding the parameters of PBMT) is needed to support the use of PBMT for this indication.

Photobiomodulation therapy for acute radiodermatitis.

PURPOSE OF REVIEW: The number of clinical trials on the use of photobiomodulation therapy (PBMT) for the management of cancer therapy-related complications is growing steadily. One of the side-effects that is under investigation is acute radiodermatitis (ARD), an inflammatory skin reaction caused by radiotherapy. In this review, an overview is given on the state of art of the application of PBMT for the prevention and management of ARD. RECENT FINDINGS: Up to now about seven clinical trials have been performed, investigating the use of PBMT in the prevention and/or management of ARD. Results demonstrate that PBMT can effectively reduce the incidence of severe ARD, decrease the accompanying pain, and improve the patients' quality of life. Moreover, the technique seems to be well tolerated in oncologic patients. SUMMARY: On the basis of the available evidence, there could be a strong recommendation to use PBMT in the prevention and management of ARD in cancer patients.

Midwives', Obstetricians', and Recently Delivered Mothers' Perceptions of Remote Monitoring for Prenatal Care: Retrospective Survey.

BACKGROUND: The Pregnancy Remote Monitoring (PREMOM) study enrolled pregnant women at increased risk of developing hypertensive disorders of pregnancy and investigated the effect of remote monitoring in addition to their prenatal follow-up. OBJECTIVE: The objective of this study was to investigate the perceptions and experiences of remote monitoring among mothers, midwives, and obstetricians who participated in the PREMOM study. METHODS: We developed specific questionnaires for the mothers, midwives, and obstetricians addressing 5 domains: (1) prior knowledge and experience of remote monitoring, (2) reactions to abnormal values, (3) privacy, (4) quality and patient safety, and (5) financial aspects. We also questioned the health care providers about which issues they considered important when implementing remote monitoring. We used a 5-point Likert scale to provide objective scores. It was possible to add free-text feedback at every question. RESULTS: A total of 91 participants completed the questionnaires. The mothers, midwives, and obstetricians reported positive experiences and perceptions of remote monitoring, although most of them had no or little prior experience with this technology. They supported a further rollout of remote monitoring in Belgium. Nearly three-quarters of the mothers (34/47, 72%) did not report any problems with taking the measurements at the required times. Almost half of the mothers (19/47, 40%) wanted to be contacted within 3 to 12 hours after abnormal measurement values, preferably by telephone. CONCLUSIONS: Although most of midwives and obstetricians had no or very little experience with remote monitoring before enrolling in the PREMOM study, they reported, based on their one-year experience, that remote monitoring was an important component in the follow-up of high-risk pregnancies and would recommend it to their colleagues and pregnant patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03246737; https://clinicaltrials.gov/ct2/show/NCT03246737 (Archived by WebCite at http://www.webcitation.org/76KVnHSYY).

Letter to the Editor concerning the article "Application of red light phototherapy in the treatment of radioactive dermatitis in patients with head and neck cancer".

The aim of this Letter to the Editor was to report some methodological shortcomings in the recently published article "Application of red light phototherapy in the treatment of radioactive dermatitis in patients with head and neck cancer" by Zhang et al. There are some issues regarding the incomplete photobiomodulation (PBM) parameters, the chosen outcome measures, and some missing reference articles. In conclusion, the results of this study should be interpreted with caution and further research is necessary.

Biophysical skin measurements to evaluate the effectiveness of photobiomodulation therapy in the prevention of acute radiation dermatitis in breast cancer patients.

PURPOSE: The purpose of this study was to evaluate objectively the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) by using biophysical skin measurements. METHODS: A randomized, placebo-controlled trial with 120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial). Patients were randomized to receive PBM (808 nm CW/905 nm pulsed, 168 mW/cm2, spot size 19.6 cm2, fluence 4 J/cm2) or placebo treatments from the first day of RT (2×/week). Biophysical skin measurements were collected to assess the skin pigmentation and barrier function. Measurements were collected at the first day of RT, a RT dose of 40 Gray (Gy), and the end of RT (66 Gy). RESULTS: The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004). The biophysical skin measures showed that the mean percentage change from the baseline transepidermal water loss (TEWL), erythema, and melanin values was significantly higher in the control than in the PBMT group at the end of RT (ps < 0.05). Logistic regression analysis revealed that the risk on moist desquamation was significantly increased for patients with a large (> 800 cc) breast volume (odds ratio = 4, p = 0.017). CONCLUSIONS: This is the first randomized controlled trial demonstrating by objective measurements that PBMT is effective in reducing the incidence of moist desquamation in breast cancer patients undergoing RT. Additionally, a large breast volume is an important risk factor for the development of moist desquamation.