Late effects following breast cancer treatment.

Improved survival after breast cancer treatment comes at a cost in the form of increased risk of late effects. A number of these are summarised in this review. The late effects can be divided in 1) late effects after locoregional treatment, e.g., lymphoedema, impaired shoulder movement, and pain; 2) consequences of systemic treatment, e.g. polyneuropathy, problems related to premature menopause, and increased risk of cardio-vascular disease; and 3) general late effects, commonly seen across all cancer types, including fatigue, insomnia, and cognitive impairment. There is a need for more knowledge about risk factors, prognoses, and the most effective treatments.

Vaginal CO2 laser therapy for genitourinary syndrome in breast cancer survivors-VagLaser study protocol: a randomized blinded, placebo-controlled trial.

BACKGROUND: Vaginal CO2 laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population. METHODS: VagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH. DISCUSSION: More randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06007027 (registered 22 August, 2023). PROTOCOL VERSION: Version 1, Date 13.11.2023.

Prognosis of breast cancer patients with brain metastasis treated with radiotherapy.

BACKGROUND: Life expectancy for patients diagnosed with metastatic breast cancer (BC) has improved in recent years, especially due to better systemic treatment. This has led to an increased incidence of brain metastases (BM), and BC is now the leading cause of BM in women. Treatment of BM primarily consists of surgery and/or radiotherapy. We aimed to investigate survival time and prognostic factors for BC patients treated with radiotherapy for BM. MATERIAL & METHODS: During the period 1st of January 2015 to 1st of June 2020, 144 consecutive BC patients treated for BM from one centre were retrospectively analyzed. The patients were either diagnosed with BM as the first metastatic lesion, or developed BM during palliative therapy for distant non-brain metastasis. The study was approved by the Central Denmark Region. RESULTS: Median age at BM diagnosis was 66 years, and 90% of the patients already had extracranial metastatic disease at BM diagnosis. Median overall survival after diagnosis of BM was 6.1 months. Short survival was observed for patients with poor performance status, leptomeningeal metastasis or more than three solid BM. Several of these factors were overrepresented in patients with estrogen receptor-positive (ER+) tumours who had poorer survival than patients with different receptor status. CONCLUSION: The number of metastatic BC patients developing BM is high, and survival following local treatment remains poor. Several prognostic factors appear to influence survival after radiotherapy. Treatment of BC patients with BM should be individualized according to performance status, leptomeningeal disease, number of BM, and receptor status of the disease.

Drug-Induced Liver Injury Caused by Capecitabine: A Case Report and a Literature Review.

Chemotherapy is widely used in cancer treatment, and the drug Capecitabine is often used in treatment of breast cancer and usually well-tolerated. Toxicity from Capecitabine typically involves hand-foot syndrome, fatigue, nausea, reduced appetite, and diarrhea, while severe liver toxicity is rarely seen. We present a case of a 63-year-old female with metastatic breast cancer, without liver metastasis, who developed a severe drug-induced liver injury (DILI) with critically elevated liver enzyme levels as reaction to Capecitabine treatment with seemingly no evident explanation as to why. The patient had a RUCAM score of 7 and a Naranjo score of 6 implying that this association between Capecitabine and the liver injury falls into the "probable" category. The patient recovered completely and was then successfully treated with other cytotoxic drugs without any sign of liver engagement. An in-depth literature search based on Pubmed database was performed to obtain information about Capecitabine, liver injury, and chemotherapy-associated acute hepatic toxicity. The following keywords were used: Capecitabine, chemotherapy, liver toxicity, and hepatic toxicity. Five studies were found showing some similarities to this case documenting hepatic injury after Capecitabine treatment including hepatic steatosis and moderately elevated liver enzymes. However, no studies were found reporting a severe DILI with highly elevated enzyme levels as immediate response to Capecitabine treatment. No reason could be identified as for why the patient developed an acute toxic liver reaction to Capecitabine. This case calls for more attention to the potential severe liver toxicity of an otherwise well-tolerated drug.

Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark.

INTRODUCTION: One in five breast cancer (BC) survivors are affected by persistent pain years after completing primary treatment. While the efficacy of psychological interventions for BC-related pain has been documented in several meta-analyses, reported effect sizes are generally modest, pointing to a need for optimisation. Guided by the Multiphase Optimization Strategy, the present study aims to optimise psychological treatment for BC-related pain by identifying active treatment components in a full factorial design. METHODS AND ANALYSIS: The study uses a 2×3 factorial design, randomising 192 women with BC-related pain (18-75 years) to eight experimental conditions. The eight conditions consist of three contemporary cognitive-behavioural therapy components, namely: (1) mindful attention, (2) decentring, and (3) values and committed action. Each component is delivered in two sessions, and each participant will receive either zero, two, four or six sessions. Participants receiving two or three treatment components will be randomised to receive them in varying order. Assessments will be conducted at baseline (T1), session by session, every day for 6 days following the first session in each treatment component, at post-intervention (T2) and at 12-week follow-up (T3). Primary outcomes are pain intensity (Numerical Rating Scale) and pain interference (Brief Pain Inventory interference subscale) from T1 to T2. Secondary outcomes are pain burden, pain quality, pain frequency, pain catastrophising, psychological distress, well-being and fear of cancer recurrence. Possible mediators include mindful attention, decentring, and pain acceptance and activity engagement. Possible moderators are treatment expectancy, treatment adherence, satisfaction with treatment and therapeutic alliance. ETHICS AND DISSEMINATION: Ethical approval for the present study was received from the Central Denmark Region Committee on Health Research Ethics (no: 1-10-72-309-40). Findings will be made available to the study funders, care providers, patient organisations and other researchers at international conferences, and published in international, peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05444101).

Increased morbidity evaluated on hospital contacts and prescriptions among 100,834 Danish breast cancer survivors.

BACKGROUND: Cardiovascular disease competes with breast cancer (BC) as the leading cause of death for females diagnosed with breast cancer. Not much is known concerning morbidity and medicine use in the short and long term after a BC diagnosis. AIM: The aim of this study was to determine acute and long-term morbidity in Danish women treated for BC. METHOD: A nationwide registry-based cohort study of 100,834 BC patients identified in the clinical database of Danish Breast Cancer Cooperative Group (DBCG) and 1,100,320 (10 per patient) age-matched Danish women without BC, serving as controls. Morbidity was studied using complete data on hospital contacts and medicinal use. RESULTS: The risk of hospital contacts was significantly increased in BC survivors compared with controls evaluated both by means of Cox regression and negative binomial regression analysis both during and after cessation of breast cancer treatment. Young age at breast cancer diagnosis was associated with the most pronounced increase in risk of hospital contacts, both during and after cessation of BC treatment. Medicinal use was significantly increased among BC patients compared to controls, both during (HR 1.27 (1.26-1.28), p < 0.0001) and after BC treatment (HR 1.18 (1.17-1.19), p < 0.0001, and present for all subgroups of medicine. CONCLUSION: Overall, BC survivors have a pronounced increase in hospital contacts and medicinal use compared to women without BC. Premenopausal status at BC diagnosis was associated with an overall higher excess morbidity and a higher burden both during and after treatment.

What Does It Take for Research to Be Rehabilitation Research?

Six recommendations to facilitate rehabilitation research and supplement existing research practices were identified. Rehabilitation practice requires research addressing different long-term multi-faceted needs and perspectives of end users, including service users, professionals, politicians, and administrators. Research in rehabilitation should therefore integrate different research traditions and methods. Rehabilitation research with a broad focus is sparse, and most of the research takes its starting point in the biomedical research tradition. Through a nominal group process, we developed recommendations to emphasize important issues in rehabilitation research.

Comparison of contrast-enhanced CT, dual-layer detector spectral CT, and whole-body MRI in suspected metastatic breast cancer: a prospective diagnostic accuracy study.

OBJECTIVES: To compare diagnostic accuracy of contrast-enhanced CT, dual-layer detector spectral CT (DL-CT), and whole-body MRI (WB-MRI) for diagnosing metastatic breast cancer. METHODS: One hundred eighty-two biopsy-verified breast cancer patients suspected of metastatic disease prospectively underwent contrast-enhanced DL-CT and WB-MRI. Two radiologists read the CT examinations with and without spectral data in consensus with 3-month washout between readings. Two other radiologists read the WB-MRI examinations in consensus. Lymph nodes, visceral lesions, and bone lesions were assessed. Readers were blinded to other test results. Reference standard was histopathology, previous or follow-up imaging, and clinical follow-up. RESULTS: Per-lesion AUC was 0.80, 0.84, and 0.82 (CT, DL-CT, and WB-MRI, respectively). DL-CT showed significantly higher AUC than CT (p = 0.001) and WB-MRI (p = 0.02). Sensitivity and specificity of CT, DL-CT, and WB-MRI were 0.66 and 0.94, 0.75 and 0.95, and 0.65 and 0.98, respectively. DL-CT significantly improved sensitivity compared to CT (p < 0.0001) and WB-MRI (p = 0.002). Per-patient AUC was 0.85, 0.90, and 0.92 (CT, DL-CT, and WB-MRI, respectively). DL-CT and WB-MRI had significantly higher AUC than CT (p = 0.04 and p = 0.03). DL-CT significantly increased sensitivity compared to CT (0.89 vs. 0.79, p = 0.04). WB-MRI had significantly higher specificity than CT (0.84 vs. 0.96, p = 0.001) and DL-CT (0.87 vs. 0.96, p = 0.02). CONCLUSIONS: DL-CT showed significantly higher per-lesion diagnostic performance and sensitivity than CT and WB-MRI. On a per-patient basis, DL-CT and WB-MRI had equal diagnostic performance superior to CT. KEY POINTS: • Spectral CT has higher diagnostic performance for diagnosing breast cancer metastases compared to conventional CT and whole-body MRI on a per-lesion basis. • Spectral CT and whole-body MRI are superior to conventional CT for diagnosing patients with metastatic breast cancer. • Whole-body MRI is superior to conventional CT and spectral CT for diagnosing bone metastases.

Breast cancer: comparison of quantitative dual-layer spectral CT and axillary ultrasonography for preoperative diagnosis of metastatic axillary lymph nodes.

BACKGROUND: Our aim was to compare the diagnostic performance of quantitative dual-layer spectral computed tomography (DLSCT) and axillary ultrasound (US) for diagnosing lymph node metastases in breast cancer patients. METHODS: DLSCT and axillary US were prospectively performed in 70 needle biopsy-verified breast cancer patients. Histopathology and imaging data were available for evaluation in 36 axillae from 34 patients. In each patient, ipsilateral, contralateral, and inguinal lymph nodes (LNs) were semiautomatically segmented, and iodine density, spectral slope, Z effective, virtual non-contrast (VNC), conventional CT HU values, and Δ contrast enhancement (ΔCE, conventional CT HU minus VNC) were measured. Using histopathology as reference, the diagnostic performance of DLSCT and axillary US was compared. RESULTS: Of 36 axillae, 23 had metastatic lymph nodes. Compared with non-metastatic LNs, metastatic LNs had significantly different iodine density (p = 0.021), spectral slope (p < 0.001), Z effective (p < 0.001), conventional CT HU values (p < 0.01), and ΔCE (p < 0.01). All DLSCT parameters were significantly different between arterial phase and portal-venous phase (p < 0.001) except for VNC (p = 0.092). ΔCE had the highest diagnostic performance (sensitivity 0.79, specificity 0.92, positive predictive value 0.95, negative predictive value 0.69) with a significantly increased sensitivity compared with conventional CT HU (p = 0.027). There were no significant differences between ΔCE and axillary US for sensitivity (p = 1.000) or specificity (p = 0.320). CONCLUSIONS: DLSCT is a promising quantitative technique for evaluating LN metastases and could potentially reduce the need for sentinel LN biopsy.

Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer.

PURPOSE: Treatment for estrogen receptor positive (ER+), human epidermal receptor 2 negative (HER2-) metastatic breast cancer (MBC) has improved with the approval of CDK 4/6 inhibitors. Clinical trials with the CDK4/6 inhibitor ribociclib, suggest that 35% to 57.5% of the patients require a dose reduction during ribociclib treatment. Data on the possible consequences of dose reduction concerning efficacy is needed. METHODS: A retrospective cohort study on patients with ER+ HER2- MBC from three Danish oncology departments. Data on tolerability and progression-free survival were collected from electronic health records. RESULTS: One hundred and twenty-eight patients with ER+ HER2- MBC who initiated ribociclib treatment between 1st of January 2018 to 31st of March 2020 were included in our analysis. Of these patients, 48.4% required one or more dose reductions. Overall median PFS was 19.2 months (CI-95% 14.3-NR). Patients with one or more dose reductions did not have decreased median PFS (19.2 months, CI-95% 14.3-NR compared to 12.2 months, CI-95% 7.3-NR, p = 0.078). Frequency of adverse events were as previously reported, with grade III and IV neutropenia occurring in 45.3% and 7% of patients, respectively. Patients treated with fulvestrant versus an aromatase inhibitor and patients with lymph node involvement at baseline had lower odds of requiring a dose reduction (ORa = 0.30, CI-95% 0.12-0.73 & ORa = 0.41, CI-95% 0.18-0.89, respectively). CONCLUSION: Our results indicate that dose reduction of ribociclib is safe and do not compromise the efficacy of the treatment. Furthermore, the study supports translation of results from the MONALEESA trials to patients treated in real-world clinical settings.

The majority of Danish breast cancer survivors on adjuvant endocrine therapy have clinically relevant sexual dysfunction: a cross-sectional study.

BACKGROUND: Impairments in sexual function are common among breast cancer survivors (BCSs), particularly in BCSs receiving adjuvant endocrine therapy (AET). Whether these impairments cause distress, thus qualifying for a more clinically relevant diagnosis of sexual dysfunction (SD), is inadequately described among BCSs and represents an important research gap. Hence, the primary aim of this study was to estimate the prevalence of clinically relevant SD, in this context: impairments with associated distress, and to identify factors associated with SD among BCSs on AET. Secondly, to explore the extent of distress caused by specific impairments in sexual function. MATERIALS AND METHODS: In this cross-sectional study of BCSs on adjuvant treatment with endocrine therapy for at least three months, participants completed an online survey comprising standardized measures of sexual and psychosocial function. Female Sexual Function Index (FSFI) and Sexual Complaint Screener - Women (SCS-W) were used to asses clinically relevant SD. Multiple regression analyses were performed to identify factors significantly associated with SD. RESULTS: In total, 333 BCSs with a mean age of 58.7 years were included in the study, of whom 227 were sexually active. Among sexually active BCSs, 134 (59%) met the criteria for having clinically relevant SD, of whom 78 (58%) perceived cancer treatment as the primary reason for their sexual problems. Factors associated with SD included vaginal dryness (adjusted OR= 2.25, 95% CI: 1.52-3.34, p < .01) and psychological well-being (adjusted OR= 1.11, 95% CI: 1.03-1.18, p < .01). Age was not related to neither prevalence of SD nor the level of distress caused by any impairment, with exception of low sexual desire. Pain in relation to intercourse was the most distressing impairment. CONCLUSION: SD was highly prevalent among sexually active BCSs on AET. Sexual health is important to address independent of the woman's age.

Municipal return to work management in cancer survivors: a controlled intervention study.

INTRODUCTION: Resuming work during or after cancer treatment has become an important target in cancer rehabilitation. PURPOSE: The aim was in a controlled trial to study the return to work (RTW) effect of an early, individually tailored vocational rehabilitation intervention targeted to improve readiness for RTW in cancer survivors. MATERIAL AND METHODS: Participants diagnosed with breast, cervix, ovary, testicular, colon-rectal, and head-and-neck cancers as well as being employed were allocated to a vocational rehabilitation intervention provided by municipal social workers (n = 83) or to usual municipal RTW management (n = 264). The intervention contained three elements: motivational communication inspired by Acceptance and Commitment Therapy by which RTW barriers were addressed, municipal cancer rehabilitation and finally employer and workplace contact. RTW effect was assessed as relative cumulative incidence proportions (RCIP) in the control and intervention group within 52 weeks of follow-up, estimated from the week where treatment ended at the hospital. RCIP was interpreted and reported as relative risk (RR) with 95% confidence intervals (CI) adjusted for gender, age cancer diagnosis, education, comorbidity, and sick leave weeks. RESULTS: Across cancer diagnoses 69 (83.1%) and 215 (81.4%) returned to work in the intervention and control group, respectively. No statistical effect was seen (RR 1.08 (95% CI 0.98-1.19)). Repeating the analyses solely for participants with breast cancer (n = 290) showed a significant effect of the intervention (RR 1.12 (95% CI 1.01-1.23)). CONCLUSION: More than 80% returned to work in both groups. However, no statistical difference in RTW effect was seen across cancer diagnoses within one year from being exposed to an early, individually tailored vocational rehabilitation intervention compared with usual municipal RTW management. TRIAL REGISTRATION NUMBER: ISRCTN50753764.

Fat fractions from high-resolution 3D radial Dixon MRI for predicting metastatic axillary lymph nodes in breast cancer patients.

PURPOSE: To assess diagnostic performance of fat fractions (FF) from high-resolution 3D radial Dixon MRI for differentiating metastatic and non-metastatic axillary lymph nodes in breast cancer patients. METHOD: High-resolution 3D radial Dixon MRI was prospectively performed on 1.5 T in 70 biopsy-verified breast cancer patients. 35 patients were available for analysis with histopathologic and imaging data. FF images were calculated as fat / in-phase. Two radiologists measured lymph node FF and assessed morphological features in one ipsilateral and one contralateral lymph node in consensus. Diagnostic performance of lymph node FF and morphological criteria were compared using histopathology as reference. RESULTS: 22 patients had metastatic axillary lymph nodes. Mean lymph node FF were 0.20 ±â€¯0.073, 0.31 ±â€¯0.079, and 0.34 ±â€¯0.15 (metastatic, non-metastatic ipsi- and non-metastatic contralateral lymph nodes, respectively). Metastatic lymph node FF were significantly lower than non-metastatic ipsi- (p <  0.001) and contralateral lymph nodes (p <  0.001). Area under the receiver operating characteristics curve for lymph node FF was 0.80 compared to 0.76 for morphological criteria (p =  0.29). Lymph node FF yielded sensitivity 0.91, specificity 0.69, positive predictive value (PPV) 0.83, and negative predictive value (NPV) 0.82, while morphological criteria yielded sensitivity 0.91, specificity 0.62, PPV 0.80, and NPV 0.80 (p =  0.71). Combining lymph node FF and morphological criteria increased diagnostic performance with sensitivity 1.00, specificity 0.67, PPV 0.86, NPV 1.00, and AUC 0.83. CONCLUSIONS: Lymph node FF from high-resolution 3D Dixon images are a promising quantitative indicator of metastases in axillary lymph nodes.

Simultaneous multislice diffusion-weighted imaging with short tau inversion recovery fat suppression in bone-metastasizing breast cancer.

PURPOSE: To compare image quality and ADC values of simultaneous multislice diffusion-weighted imaging (mb-DWI) with that of conventional DWI (c-DWI) using short tau inversion recovery fat saturation (STIR) in women with bone-metastasizing breast cancer. METHOD: c-DWI and mb-DWI were acquired at 1.5 T in 23 breast cancer patients from skull base to mid thighs. mb-DWI was compared to c-DWI in terms of subjective image quality, artefacts and bone metastasis lesion conspicuity assessed on a 5-point Likert scale. ADC values of different organs as well as bone metastasis ADC values were compared between c-DWI and mb-DWI. RESULTS: mb-DWI reduced scan time by 48 % compared with c-DWI (1 min 58 s vs. 3 min 45 s per station). mb-DWI provided similar subjective image quality (3.8 vs. 3.7, p = 0.70), number of artefacts (50 vs. 56), severity of these (4.6 vs. 4.7, p = 0.11), and lesion conspicuity (4.2 vs. 4.4, p = 0.31) compared to c-DWI. mb-DWI showed lower mean ADC values in liver (0.5 × 10-3 mm2/s vs. 0.7 × 10-3 mm2/s, p = 0.002) and erector spine muscle (1.3 × 10-3 mm2/s vs. 1.5 × 10-3 mm2/s, p < 0.001). Bone metastasis ADC values from mb-DWI were 6.4 % lower than c-DWI (95 % confidence interval: 5.4%-7.4%, p < 0.001). CONCLUSIONS: mb-DWI provides similar subjective image quality to c-DWI with the same level of artefacts. Although bone metastasis ADC values were lower, mb-DWI can substantially reduce scan times of whole-body DWI in women with bone-metastasizing breast cancer.

[Integration af specialiseret palliation og onkologi].

Palliative care (PC) is an approach, which improves the quality of life (QoL) of patients and their families facing problems associated with life-threatening illness. Hospital-based specialised PC alongside cancer treatment shows better symptom management, QoL, satisfaction with care, and less psychological distress. Strong recommendations have been given to integrate PC and cancer care. Systematic screening of symptoms and needs, use of standardised care pathways, better competencies in PC at all levels, more research and palliative medicine as a new speciality in Denmark are future perspectives.

Advance care planning and place of death, hospitalisation and actual place of death in lung, heart and cancer disease: a randomised controlled trial.

OBJECTIVES: Advance care planning (ACP) can be a way to meet patients' end-of-life preferences and enhance awareness of end-of-life care. Thereby it may affect actual place of death (APOD) and decrease the rate of hospitalisations. The aim was to investigate if ACP among terminally ill patients with lung, heart and cancer diseases effects fulfilment of preferred place of death (PPOD), amount of time spent in hospital and APOD. METHODS: The study was designed as a randomised controlled trial. Patients were assessed using general and disease-specific criteria and randomised into groups: one received usual care and one received usual care plus ACP. The intervention consisted of a discussion between a healthcare professional, the patient and their relatives about preferences for end-of-life care. The discussion was documented in the hospital file. RESULTS: In total, 205 patients were randomised, of which 111 died during follow-up. No significant differences in fulfilment of PPOD (35% vs 52%, p=0.221) or in amount of time spent in hospital among deceased patients (49% vs 23%, p=0.074) were found between groups. A significant difference in APOD was found favouring home death in the intervention group (17% vs 40%, p=0.013). CONCLUSION: Concerning the primary outcome, fulfilment of PPOD, and the secondary outcome, time spent in hospital, no differences were found. A significant difference concerning APOD was found, as more patients in the intervention group died at home, compared with the usual care group. TRIAL REGISTRATION NUMBER: NCT01944813.

Key metabolic parameters change significantly in early breast cancer survivors: an explorative PILOT study.

BACKGROUND: With increasing number of breast cancer survivors, more attention is drawn to long-term consequences of curative cancer treatment. Adjuvant treatment of breast cancer patients is associated with several unfavorable medical conditions, including dyslipidemia, insulin resistance, and obesity, potentially leading to cardiovascular disease and/or the metabolic syndrome. The aim of this explorative study is to investigate metabolic side effects of adjuvant treatment in breast cancer patients. METHODS: A cohort of 13 premenopausal and 20 postmenopausal women with early stage breast cancer were extensively examined prior to, immediately after and 1 year after ended adjuvant chemotherapy and compared with healthy controls (N = 36) matched by age and menopausal status. Repeated examinations included: anthropometric measures, DEXA scans, 24-h blood pressure measurements, and blood samples [high sensitivity CRP, lipid profile and glucose metabolism, including homeostatic model assessment (HOMA)]. RESULTS: At baseline, breast cancer patients were similar to healthy controls regarding all measures. From baseline to 1-year post-treatment specific components of the metabolic syndrome increased significantly in premenopausal breast cancer patients; body fat (P = 0.01), triglycerides (P = 0.03), waist circumference (P = 0.008) and diastolic blood pressure (P = 0.04). In postmenopausal patients, waist circumference also increased significantly (P = 0.03), and High density lipoprotein (HDL) cholesterol decreased significantly (P = 0.05). CONCLUSIONS: Specific components of the metabolic syndrome changed significantly during chemotherapy in early stage breast cancer patients. After 1 year, several key parameters remained pathologically changed. Premenopausal breast cancer patients seemed to be especially prone to develop these unfavorable changes. Trial registration ClinicalTrial.gov, registration number NCT02652975. Registered 15 December 2015-Retrospectively registered, https://clinicaltrials.gov/ .

Advance care planning for patients and their relatives.

BACKGROUND: Advance care planning (ACP) has been suggested to improve the quality of life (QoL) and mental wellbeing in severely ill patients and their relatives. AIM: To investigate the effects of ACP among patients with lung, heart and cancer diseases with an estimated life-span of up to 12 months. METHODS: Patients and relatives were randomised into two groups: one receiving usual care and one receiving ACP and usual care. Themes from the ACP discussion were documented in patients' electronic medical file. Participants completed self-reported questionnaires four to five weeks after randomisation. FINDINGS: In total, 141 patients and 127 relatives participated. No significant differences were found according to outcomes. However, patients with non-malignant diseases had the highest level of anxiety and depression; these patients seemed to benefit the most from ACP, though not showing statistically significant results. CONCLUSION: No significant effects of ACP among patients with lung, heart, and cancer diseases and their relatives regarding HRQoL, anxiety, depression, and satisfaction with healthcare were found.