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.

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.

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.

Systematic screening and assessment of psychosocial well-being and care needs of people with cancer.

BACKGROUND: Receiving a diagnosis of cancer and the subsequent related treatments can have a significant impact on an individual's physical and psychosocial well-being. To ensure that cancer care addresses all aspects of well-being, systematic screening for distress and supportive care needs is recommended. Appropriate screening could help support the integration of psychosocial approaches in daily routines in order to achieve holistic cancer care and ensure that the specific care needs of people with cancer are met and that the organisation of such care is optimised. OBJECTIVES: To examine the effectiveness and safety of screening of psychosocial well-being and care needs of people with cancer. To explore the intervention characteristics that contribute to the effectiveness of these screening interventions. SEARCH METHODS: We searched five electronic databases in January 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, and CINAHL. We also searched five trial registers and screened the contents of relevant journals, citations, and references to find published and unpublished trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) that studied the effect of screening interventions addressing the psychosocial well-being and care needs of people with cancer compared to usual care. These screening interventions could involve self-reporting of people with a patient-reported outcome measures (PROMs) or a semi-structured interview with a screening interventionist, and comprise a solitary screening intervention or screening with guided actions. We excluded studies that evaluated screening integrated as an element in more complex interventions (e.g. therapy, coaching, full care pathways, or care programmes). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed methodological quality for each included study using the Cochrane tool for RCTs and the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool for NRCTs. Due to the high level of heterogeneity in the included studies, only three were included in meta-analysis. Results of the remaining 23 studies were analysed narratively. MAIN RESULTS: We included 26 studies (18 RCTs and 8 NRCTs) with sample sizes of 41 to 1012 participants, involving a total of 7654 adults with cancer. Two studies included only men or women; all other studies included both sexes. For most studies people with breast, lung, head and neck, colorectal, prostate cancer, or several of these diagnoses were included; some studies included people with a broader range of cancer diagnosis. Ten studies focused on a solitary screening intervention, while the remaining 16 studies evaluated a screening intervention combined with guided actions. A broad range of intervention instruments was used, and were described by study authors as a screening of health-related quality of life (HRQoL), distress screening, needs assessment, or assessment of biopsychosocial symptoms or overall well-being. In 13 studies, the screening was a self-reported questionnaire, while in the remaining 13 studies an interventionist conducted the screening by interview or paper-pencil assessment. The interventional screenings in the studies were applied 1 to 12 times, without follow-up or from 4 weeks to 18 months after the first interventional screening. We assessed risk of bias as high for eight RCTs, low for five RCTs, and unclear for the five remaining RCTs. There were further concerns about the NRCTs (1 = critical risk study; 6 = serious risk studies; 1 = risk unclear).Due to considerable heterogeneity in several intervention and study characteristics, we have reported the results narratively for the majority of the evidence.In the narrative synthesis of all included studies, we found very low-certainty evidence for the effect of screening on HRQoL (20 studies). Of these studies, eight found beneficial effects of screening for several subdomains of HRQoL, and 10 found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We found very low-certainty evidence for the effect of screening on distress (16 studies). Of these studies, two found beneficial effects of screening, and 14 found no effects of screening. We judged the overall certainty of the evidence for the effect of screening on HRQoL to be very low. We found very low-certainty evidence for the effect of screening on care needs (seven studies). Of these studies, three found beneficial effects of screening for several subdomains of care needs, and two found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We judged the overall level of evidence for the effect of screening on HRQoL to be very low. None of the studies specifically evaluated or reported adverse effects of screening. However, three studies reported unfavourable effects of screening, including lower QoL, more unmet needs, and lower satisfaction.Three studies could be included in a meta-analysis. The meta-analysis revealed no beneficial effect of the screening intervention on people with cancer HRQoL (mean difference (MD) 1.65, 95% confidence interval (CI) -4.83 to 8.12, 2 RCTs, 6 months follow-up); distress (MD 0.0, 95% CI -0.36 to 0.36, 1 RCT, 3 months follow-up); or care needs (MD 2.32, 95% CI -7.49 to 12.14, 2 RCTs, 3 months follow-up). However, these studies all evaluated one specific screening intervention (CONNECT) in people with colorectal cancer.In the studies where some effects could be identified, no recurring relationships were found between intervention characteristics and the effectiveness of screening interventions. AUTHORS' CONCLUSIONS: We found low-certainty evidence that does not support the effectiveness of screening of psychosocial well-being and care needs in people with cancer. Studies were heterogeneous in population, intervention, and outcome assessment.The results of this review suggest a need for more uniformity in outcomes and reporting; for the use of intervention description guidelines; for further improvement of methodological certainty in studies and for combining subjective patient-reported outcomes with objective outcomes.

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.

Qualitative research on the Belgian Cancer Rehabilitation Evaluation System (CARES): An evaluation of the content validity and feasibility.

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.

The use of low-level light therapy in supportive care for patients with breast cancer: review of the literature.

Breast cancer is the most common cancer in women worldwide, with an incidence of 1.7 million in 2012. Breast cancer and its treatments can bring along serious side effects such as fatigue, skin toxicity, lymphedema, pain, nausea, etc. These can substantially affect the patients' quality of life. Therefore, supportive care for breast cancer patients is an essential mainstay in the treatment. Low-level light therapy (LLLT) also named photobiomodulation therapy (PBMT) has proven its efficiency in general medicine for already more than 40 years. It is a noninvasive treatment option used to stimulate wound healing and reduce inflammation, edema, and pain. LLLT is used in different medical settings ranging from dermatology, physiotherapy, and neurology to dentistry. Since the last twenty years, LLLT is becoming a new treatment modality in supportive care for breast cancer. For this review, all existing literature concerning the use of LLLT for breast cancer was used to provide evidence in the following domains: oral mucositis (OM), radiodermatitis (RD), lymphedema, chemotherapy-induced peripheral neuropathy (CIPN), and osteonecrosis of the jaw (ONJ). The findings of this review suggest that LLLT is a promising option for the management of breast cancer treatment-related side effects. However, it still remains important to define appropriate treatment and irradiation parameters for each condition in order to ensure the effectiveness of LLLT.

Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS(®) laser therapy in breast cancer patients.

PURPOSE: The aim of this study was to assess the effectiveness and acceptability of photobiomodulation using MLS(®) laser therapy (LT) in the management of acute radiation dermatitis (RD). METHODS: We compared two successive groups of breast cancer patients undergoing identical radiotherapy regimens post-lumpectomy. Both groups received our standard skin care but the second group received six additional LT sessions (beam area 19.635 cm(2), 0.168 W/cm(2), 4 J/cm(2)), starting at fraction 20 of radiotherapy (control and LT group, N = 41 and 38, respectively). The clinical outcomes were the severity of RD (using the Radiation Therapy Oncology Group [RTOG] criteria and the Radiotherapy-Induced Skin Reaction Assessment Scale [RISRAS]) and dermatology-specific quality of life (Skindex-16) before the start of LT and at the end of radiotherapy. Secondary outcomes were patients' ratings of skin care or LT (pleasantness, soothing effect, and global satisfaction). RESULTS: Skin toxicity was equivalent between the groups before the start of LT but significantly differed at the end of radiotherapy, with an aggravation in the control but not in the LT group (e.g., 29 versus 3 % of RTOG grade 2 RD, respectively, P < 0.005). We found no significant group differences with respect to quality of life. However, the RISRAS subjective score decreased in the LT group only, implying a decreased impact of RD on patients' quality of life. Finally, patients' ratings were significantly higher for LT than for standard care. CONCLUSIONS: These findings suggest that LT might be effective to manage acute RD and warrant further research. CLINICAL TRIAL NUMBER: NCT01932073. https://clinicaltrials.gov/ct2/show/NCT01932073 .

Immediate Administration of Zoledronic Acid Reduces Aromatase Inhibitor-Associated Bone Loss in Postmenopausal Women With Early Breast Cancer: 12-month analysis of the E-ZO-FAST trial.

BACKGROUND: Letrozole is a proven and effective adjuvant therapy in postmenopausal women with hormone receptor-positive (HR(+)) early breast cancer (EBC). As with other aromatase inhibitors (AIs), long-term letrozole administration is associated with decreased bone mineral density (BMD) and increased fracture risk. This study compared potential bone-protecting effects of immediate vs. delayed administration of zoledronic acid (ZOL) in patients with EBC receiving adjuvant letrozole. PATIENTS AND METHODS: Patients with HR(+) EBC in whom adjuvant letrozole treatment was initiated (2.5 mg/day for 5 years) were randomized to immediate ZOL treatment (immediate ZOL) or delayed ZOL treatment (delayed ZOL) (both at 4 mg every 6 months). Patients in the delayed ZOL group received ZOL only for a BMD T-score that decreased to < -2.0 (lumbar spine [LS] or total hip [TH]) or for fracture. The primary endpoint was percentage change in the LS BMD at month 12. Patients were stratified by established or recent postmenopausal status, baseline T-scores, and adjuvant chemotherapy history. RESULTS: At 12 months, the LS BMD increased in the immediate ZOL group (+2.72%) but decreased in the delayed ZOL group (-2.71%); the absolute difference between groups was significant (5.43%; P < .0001). Across all subgroups, patients receiving immediate ZOL had significantly increased LS and TH BMD vs. those who received delayed ZOL (P < .0001). Differences in fracture incidence or disease recurrence could not be ascertained because of early data cutoff and low incidence of events. Adverse events were generally mild, transient, and consistent with the known safety profiles of both agents. CONCLUSION: Immediate ZOL administration effectively prevented BMD loss and increased BMD in postmenopausal women with HR(+) EBC receiving adjuvant letrozole, regardless of BMD status at baseline.