A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.

PURPOSE: To investigate the efficacy of a novel, multi-active emollient in preventing and managing acute radiation dermatitis (ARD) in breast cancer patients undergoing moderate hypofractionated (HF) radiotherapy (RT) compared to standard of care. METHODSA: A monocentric, open-label, randomized clinical trial (RCT) with breast cancer patients receiving moderate HF (dose: 40.05-55.86 Gy, fractions: 15-21) was conducted between January 2022 and May 2023. The experimental group received the novel emollient, while the control group received the standard skin care. Patients applied the skin care products twice daily during the complete RT course. The primary outcome was the severity of ARD at the final RT session measured by the modified Radiation Therapy Oncology Group (RTOG) criteria. Secondary outcomes included patient symptoms, quality of life (QoL), and treatment satisfaction. RESULTS: A total of 100 patients with 50 patients per group were enrolled. In the control group, 50% of the patients developed RTOG grade 1 ARD and 48% grade 2 or higher, while in the experimental group, the severity of ARD was significantly lower with 82% grade 1 and 16% grade 2 ARD (P = .013, χ2-test). The frequency and severity of xerosis were significantly lower in the experimental compared to the control group (Ps ≤ .036, Mann Whiney U test). The impact of ARD on the QoL was low, and treatment satisfaction was high in both groups, with no significant difference. CONCLUSION: This RCT shows that the novel, multi-active emollient significantly reduced the ARD RTOG grade. Research in a more diverse patient population is warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04929808 (11/06/2021).

A long-term follow-up of early breast cancer patients treated with photobiomodulation during conventional fractionation radiotherapy in the prevention of acute radiation dermatitis.

OBJECTIVES: The evidence demonstrating the efficacy 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 disease-free survival (DFS), cancer-free 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/cm2 ) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During follow-up (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the first 5 years after the end of RT. The DFS, CFS, and OS were estimated. RESULTS: At a median follow-up time of 66 months (range 4-81), there was no significant 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 first to describe the results of a long-term follow-up in early-stage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not influence the locoregional recurrence, the development of new primary tumors, or OS.

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.

The Effectiveness of a Novel Skin Barrier Protectant in the Management of Acute Radiation Dermatitis: A Case Series.

OBJECTIVE: Acute radiation dermatitis (ARD) is a frequent adverse effect in patients with cancer undergoing radiotherapy (RT). The aim of this case series is to evaluate the effect of a novel skin barrier protectant in patients with ARD. METHODS: The skin barrier protectant was used in four patients with different cancer types undergoing RT at two clinical sites. All patients received the standard institutional skincare alongside the novel skin barrier protectant. The skin reactions were evaluated by an RT nurse using the modified version of the Radiation Therapy Oncology Group criteria. RESULTS: At the final RT session, three of four patients developed erythema with or without dry desquamation. One patient presented only a minor patchy moist wound. Overall, the pain and pruritus due to ARD was low or nonexistent. No adverse events related to the skin barrier protectant were reported. CONCLUSIONS: This case series demonstrates the beneficial effects and safety of the novel skin barrier protectant in the management of ARD in patients with cancer of different etiologies. These results lay the foundation for future studies with larger, more homogeneous patient populations; a well-defined application scheme; and a stricter study design.

Vaginal mucositis in patients with gynaecological cancer undergoing (chemo-)radiotherapy: a retrospective analysis.

The objective of this retrospective analysis was to determine the incidence and extent of vaginal mucositis (VM) in women with gynaecological cancer undergoing external (chemo)radiation therapy (CRT). A retrospective analysis was set up to collect data on the incidence and severity of VM in women treated with external pelvic RT for gynaecological cancer at the Jessa Hospital, Hasselt and ZOL, Genk, BE between January 2017 and June 2018. At the start and end of their external (C)RT, they rated the frequency and intensity of five common symptoms of VM. Thirty-three patients treated with RT for gynaecological cancer met the inclusion criteria. A non-negligible proportion of patients already experienced at least one VM symptom to any degree before the start of RT, a proportion that further increased towards the end of the RT (73%). At the end of RT, on average, about 25% of these patients reported moderate-to-severe symptoms (against about 7% before the (C)RT). These results suggest that VM is a rather frequent side effect in gynaecological cancer patients that aggravates during treatment up to a moderate severity level. Although the small sample size, these data highlight the need for attention to VM.Impact StatementWhat is already known about this topic? Radiotherapy plays an important role in the treatment of gynaecological malignancies. A debilitating complication in patients undergoing pelvic radiotherapy is vaginal mucositis, an inflammation of the vaginal mucosal lining. To date, the incidence of vaginal mucositis is still not well documented.What this paper adds? A non-negligible proportion of patients already experienced at least one symptom related to vaginal mucositis before the start of radiotherapy. Most patients presented mild to moderate vaginal mucositis symptoms at the end of external pelvic radiotherapy. Burning sensation, pruritus, and pain were the most frequently documented radiotherapy-induced complications.The implications of this paper: Vaginal mucositis is an underrated side effect of pelvic radiotherapy that needs to be tackled multidisciplinary by a team of nurses, radiotherapists, oncologists, and gynaecologists. The team should tackle the complication from the start of radiotherapy by using the most appropriate measures. Due to a possible link between acute vaginal mucositis and late vaginal toxicity, the team needs to follow-up patient's post-radiotherapy to support patients in late complications and advise/encourage patients in performing vaginal dilatation to prevent vaginal stenosis.

Evaluating the Effectiveness of a Novel Skin Barrier Protectant in a Patient with Acute Radiodermatitis of the Vulva: A Case Report.

OBJECTIVE: To evaluate the use of a novel skin barrier protectant in a patient treated with radiotherapy for vulvar cancer. METHODS: This case report was conducted in a radiotherapy department with two women undergoing radiotherapy for vulvar carcinoma. A novel skin barrier protectant was evaluated in one patient; the other underwent the institutional standard skin care protocol. Skin reactions and pain were evaluated using the Radiotherapy Oncology Group Criteria. MAIN RESULTS: The patient who was treated with the skin protectant showed accelerated healing toward the end of radiotherapy, and this was accompanied with a decrease in pain (maximum pain score 6/10). In comparison, the patient treated with the standard skin care protocol had an extended healing process, experienced a higher pain level (maximum pain score 9/10), and required more nursing care. CONCLUSIONS: This case report is the first to suggest that this novel skin barrier protectant could effectively manage acute radiodermatitis in patients with cancer. This case report hopes to lay the foundation for future randomized controlled trials with a larger and broader patient population.

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.

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.

Prevention of acute radiodermatitis by photobiomodulation: A randomized, placebo-controlled trial in breast cancer patients (TRANSDERMIS trial).

OBJECTIVE: Acute radiodermatitis (RD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute RD in breast cancer (BC) patients undergoing RT. METHODS: This study was a randomized, placebo-controlled trial including 120 BC patients that underwent an identical RT regimen post-lumpectomy. Patients were randomly assigned to the laser therapy (LT) or placebo group, with 60 patients in each group. Laser or placebo treatments were applied 2 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 ). Skin reactions were scored based on the criteria of the Radiation Therapy Oncology Group (RTOG) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The patients completed the Skindex-16 questionnaire to evaluate their quality of life. All the measurements were collected at the first day, at a RT dose of 40 Gray (Gy), and at the end of RT (total dose 66 Gy). RESULTS: At a RT dose of 40 Gy, there was no significant difference between the groups in the distribution of RTOG grades. However, at the end of RT the severity of the skin reactions significantly differed between the two groups (P = 0.004), with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g., moist desquamation) in the placebo group (30% vs. 6.7%, for the placebo and laser group, resp.). The objective RISRAS score confirmed these results. In addition, the Skindex-16 and RISRAS subjective score demonstrated that the patients' quality of life was significantly better in the LT than in the control group. CONCLUSIONS: The results of this trial show that PBMT is an effective tool to prevent the development of grade 2 acute RD or higher in BC patients. In addition, it also reduces the patients' symptoms related to RD. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

The utilization of formal and informal home care by older patients with cancer: a Belgian cohort study with two control groups.

BACKGROUND: The purpose of this paper is to analyse the utilization of formal and informal home care among older patients with cancer (OCP) and to compare this with middle-aged patients with cancer (MCP) and older patients without cancer (ONC). Additionally, we examined predictors of transitions towards formal care one year after a cancer diagnosis. METHODS: OCP and MCP had to be recruited within three months after a cancer diagnosis and have an estimated life expectancy over six months. ONC consisted of patients without known cancer, seen by the general practitioner. Formal and informal care were compared between the patient groups at baseline, i.e. shortly after a cancer diagnosis and changes in care were studied after one year. RESULTS: A total of 844 patients were evaluable for formal care at baseline and 469 patients (56%) at follow-up. At baseline, about half of older adults and 18% of MCP used formal care, while about 85% of cancer patients and 57% ONC used informal care. Formal care increased for all groups after one year though not significantly in OCP. The amount of informal care only changed in MCP which decreased after one year. Cancer-related factors and changes in need factors predict a transition towards formal care after a cancer diagnosis. CONCLUSIONS: A cancer diagnosis has a different impact on the use of formal and informal care than ageing as such. The first year after a cancer diagnosis is an important time to follow-up on the patients' needs for home 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.

Validation of the flemish CARES, a quality of life and needs assessment tool for cancer care.

BACKGROUND: The Cancer Rehabilitation Evaluation System (CARES) is a quality of life (QOL) and needs assessment instrument of US origin that was developed in the 90's. Since November 2012 the copyright and user fee were abolished and the instrument became publicly available the present study aims to reinvestigate the psychometric properties of the CARES for the Flemish population in Belgium. METHODS: The CARES was translated into Flemish following a translation-back translation process. A sample of 192 cancer patients completed the CARES, concurrent measures, and questions on socio-demographic and medical data. Participants were asked to complete the CARES a second time 1 week later, followed by some questions on their experiences with the instrument. Internal consistency, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the CARES were subsequently assessed. RESULTS: The Flemish CARES version demonstrated excellent reliability with high internal consistency (range .87-.96) and test-retest ratings (range .70-.91) for all summary scales. Factor analysis replicated the original factor solution of five higher order factors with factor loadings of .325-.851. Correlations with other instruments ranging from |.43|-|.75| confirmed concurrent validity. Feasibility was indicated by the low number of missing items (mean 2.3; SD 5.0) and positive feedback of participants on the instrument. CONCLUSIONS: The Flemish CARES has strong psychometric properties and can as such be a valid tool to assess cancer patients' QOL and needs in research, for example in international comparisons. The positive feedback of participants on the CARES support the usefulness of this tool for systematic assessment of cancer patients' well-being and care needs in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02282696 (July 16, 2014).

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 .

Assessing cancer patients' quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity.

BACKGROUND: The prevalence of cancer increases every year, leading to a growing population of patients and survivors in need for care. To achieve good quality care, a patient-centered approach is essential. Correct and timely detection of needs throughout the different stages of the care trajectory is crucial and can be supported by the use of screening and assessment in a stepped-care approach. The Cancer Rehabilitation Evaluation System (CARES) is a valuable and comprehensive quality of life and needs assessment instrument. For use in Flemish research and clinical practice, the CARES tool was translated for the Dutch-speaking part of Belgium (Flanders) from its original English format. This protocol paper describes the translation and revalidation of this Flemish CARES version. METHODS: After forward-backward translation of the CARES into Flemish we aim to recruit 150 adult cancer patients with a primary cancer diagnosis (stage I, II or III) for validation. In this study with a combination of qualitative and a quantitative approach, qualitative data will be collected through focus groups and supplemented by two phases of quantitative data collection: i) an initial patient survey containing questions on socio-demographic and medical data, the CARES and seven concurrent instruments; and ii) a second survey administered after 1 week containing the CARES and supplementary questions to explore their impressions on the content and the feasibility of the CARES. DISCUSSION: With this extensive data collection process, psychometric validity of the Flemish CARES can be tested thoroughly using classical test theory. Internal consistency of summary scales, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the instrument will be examined. If the Flemish CARES version is found reliable, valid and feasible, it will be used in future research and clinical practice. Comprehensive assessment with the CARES in a stepped-care approach can facilitate timely identification of cancer patients' psychosocial concerns and care needs so it can contribute to efficient provision of patient-centered quality care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02282696 (July 16, 2014).

Loneliness in patients with cancer: the first year after cancer diagnosis.

OBJECTIVES: We studied the frequency and evolution of social and emotional loneliness in older cancer patients in comparison with younger cancer patients and older people without cancer. We evaluated if changes in common cancer-related and ageing-related problems such as fatigue, cognitive functioning and functional status contributed to the occurrence of loneliness. METHODS: This study was part of the KLIMOP study (Dutch acronym for project on older cancer patients in Belgium and the Netherlands) and included older (≥70 years) and younger cancer patients (50-69 years) and older people without cancer. Data were collected at baseline and 1-year follow-up. Loneliness was measured with the loneliness scale of De Jong-Gierveld. The relationship between loneliness after 1 year and changes in fatigue, cognitive functioning and functional status was tested in multivariate logistic regression analyses. RESULTS: Data were available for 475 participants. At baseline, older cancer patients were less lonely compared with older people without cancer. After 1 year, the frequency of emotional loneliness had significantly increased for older cancer patients (26-42%, p < 0.001) and had reached levels of older people without cancer. Emotional loneliness also increased for younger cancer patients (25-34%, p = 0.02), but not for older people without cancer (40-38%, p = 0.69). Frequency of social loneliness did not change significantly. People who were persistently fatigued and people who became or were persistently impaired on cognitive functioning were at increased risk of becoming lonely. CONCLUSION: Loneliness, in particular emotional loneliness, is a common problem in cancer patients, and its frequency changes considerably over time.

A cohort study on the evolution of psychosocial problems in older patients with breast or colorectal cancer: comparison with younger cancer patients and older primary care patients without cancer.

BACKGROUND: Although older cancer survivors commonly report psychosocial problems, the impact of both cancer and ageing on the occurrence of these problems remains largely unknown. The evolution of depression, cognitive functioning, and fatigue was evaluated in a group of older cancer patients in comparison with a group of younger cancer patients and older persons without cancer. METHODS: Older (≥70 years) and younger cancer patients (50-69 years) with breast or colorectal cancer stage I-III, and older persons without cancer (≥70 years) were included. Data were collected at baseline and one year follow-up and were available for 536 persons. Depression was evaluated with the 15-item Geriatric Depression Scale. Cognitive functioning was measured with the cognitive functioning subscale of the European Organization for Research and Treatment of Cancer. Fatigue was measured with a Visual Analogue Scale. Risk factors for depression, cognitive functioning, and fatigue were analysed using multivariate logistic regression analyses. Risk factors included cancer- and ageing-related factors such as functional status, cancer treatment, and comorbidities. RESULTS: The evolution of psychosocial problems was similar for the group of older (N = 125) and younger cancer patients (N = 196): an increase in depression (p < 0.01), slight worsening in cognitive functioning (p = 0.01), and no clear change in fatigue. Also, compared to the group of people without cancer (N = 215), the differences were small and after one year of follow-up only depression was more frequent in older cancer patients compared to older persons without cancer (18% versus 9%, p = 0.04). In multivariate analyses the main risk factors for psychosocial problems after one year follow-up were changes in functional status and presence of baseline depression, fatigue, or cognitive impairment. CONCLUSION: Over the course of one year after a diagnosis of cancer, cancer patients face increasing levels of depression and increasing difficulties in cognitive functioning. The main risk factor for psychosocial problems was presence of the problem at baseline. This calls for regular screening for psychosocial problems and exchange of information on psychosocial functioning between different health care providers and settings during the treatment and follow-up trajectory of cancer patients.

Geriatric screening tools are of limited value to predict decline in functional status and quality of life: results of a cohort study.

BACKGROUND: Geriatric screening tools are increasingly implemented in daily practice, especially in the oncology setting, but also in primary care in some countries such as the Netherlands. Nonetheless, validation of these tools regarding their ability to predict relevant outcomes is lacking. In this study we evaluate if geriatric screening tools predict decline in functional status and quality of life after one year, in a population of older cancer patients and an older primary care population without cancer with a life expectancy of at least six months. METHODS: Older cancer patients and a general older primary care population without a history of cancer (≥ 70 years) were included in an on-going prospective cohort study. Data were collected at baseline and after one-year follow-up. Functional decline was based on the Katz Index and Lawton IADL-scale and was defined as deterioration on one or more domains. Decline in quality of life was measured using the global health related subscale of the EORTC QLQ-C30, and was defined as a decline ≥ 10 points. The selected geriatric screening tools were the abbreviated Comprehensive Geriatric Assessment, Groningen Frailty Indicator, Vulnerable Elders Survey-13, and G8. We calculated sensitivity, specificity, predictive values, and odds ratios to assess if normal versus abnormal scores predict functional decline and decline in quality of life. RESULTS: One-year follow-up data were available for 134 older cancer patients and 220 persons without cancer. Abnormal scores of all screening tools were significantly associated with functional decline. However, this was only true for older persons without cancer, and only in univariate analyses. For functional decline, sensitivity ranged from 54% to 71% and specificity from 33% to 66%. For decline in quality of life, sensitivity ranged from 40% to 67% and specificity from 37% to 54%. CONCLUSION: In older persons with a relatively good prognosis, geriatric screening tools are of limited use in identifying persons at risk for decline in functional status or quality of life after one year. Hence, a geriatric screening tool cannot be relied on in isolation, but they do provide very valuable information and may prompt physicians to also consider different aspects of functioning.

Study protocol of KLIMOP: a cohort study on the wellbeing of older cancer patients in Belgium and the Netherlands.

BACKGROUND: Cancer is mainly a disease of older patients. In older cancer patients, additional endpoints such as quality of survival and daily functioning might be considered equally relevant as overall or disease free survival. However, these factors have been understudied using prospective designs focussing on older cancer patients. Therefore, this study will focus on the impact of cancer, ageing, and their interaction on the long-term wellbeing of older cancer patients. METHODS/DESIGN: This study is an observational cohort study. We aim to recruit 720 cancer patients above 70 years with a new diagnosis of breast, prostate, lung or gastrointestinal cancer and two control groups: one control group of 720 patients above 70 years without a previous diagnosis of cancer and one control group of 720 cancer patients between 50 - 69 years newly diagnosed with breast, prostate, lung or gastrointestinal cancer. Data collection will take place at inclusion, after six months, after one year and every subsequent year until death or end of the study. Data will be collected through personal interviews (consisting of socio-demographic information, general health information, a comprehensive geriatric assessment, quality of life, health locus of control and a loneliness scale), a handgrip test, assessment of medical records, two buccal swabs and a blood sample from cancer patients (at baseline). As an annex study, caregivers of the participants will be recruited as well. Data collection for caregivers will consist of a self-administered questionnaire examining depression, coping, and burden. DISCUSSION: This extensive data collection will increase insight on how wellbeing of older cancer patients is affected by cancer (diagnosis and treatment), ageing, and their interaction. Results may provide new insights, which might contribute to the improvement of care for older cancer patients.

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.