Tattoo-Associated Skin Reactions: A Danish Population-Based Survey in 5,914 Tattooed Individuals.

BACKGROUND: In Europe, Australia, and the USA, the estimated overall prevalence of tattooing is around 10-20%. Tattoo ink often comprises harmful chemicals and epidemiological studies on adverse effects of tattoos are lacking. OBJECTIVES: We aimed to estimate the prevalence of tattoo-associated skin reactions in the general Danish population and describe individuals with tattoo-associated skin reactions by socio-demographic factors and tattoo characteristics. METHODS: The study was based on respondents aged 16 years or older from a population-based 2021 survey entitled "How are you?" conducted in the Central Denmark Region (n = 33,925). Logistic regression was used to characterise individuals with tattoo-associated skin reactions by socio-demographic factors (gender, age, educational level, and ethnic background). Also, the relationship between size, age and colour of the tattoo, and tattoo-associated skin reactions was studied. Model 1 was adjusted for all socio-demographic variables (gender, age, educational level, and ethnic background); model 2, for all socio-demographic variables and tattoo characteristics (size, age, and colour). RESULTS: In total, 21.1% reported that they had at least one tattoo, 10.2% hereof reported that they had experienced tattoo-associated skin reactions (itching, pain, inflammation, and swelling) beyond the first 3 weeks after the tattoo was made. Lower age (16-44 years) (adjusted odds ratio (AOR) ≥1.75), larger tattoos (AOR ≥1.61) and having had tattoos for more than 10 years (AOR = 2.92, 95% confidence interval 1.45-5.88) increased the odds of tattoo-associated skin reactions. In general, tattooed individuals with colours other than black had higher odds of tattoo-associated skin reactions. CONCLUSION: Among participants with at least one tattoo, 10.2% had experienced tattoo-associated skin reactions beyond the first 3 weeks after their tattoo was made. This finding highlights the need for safer tattoo inks to prevent the adverse health problems experienced by many individuals with tattoos.

Single-nucleotide polymorphisms and the effectiveness of taxane-based chemotherapy in premenopausal breast cancer: a population-based cohort study in Denmark.

PURPOSE: Taxane-based chemotherapy is the primary treatment for premenopausal breast cancer. Although being inconsistent, research suggests that variant alleles alter pharmacokinetics through reduced function of OATP transporters (limiting hepatic uptake), CYP-450 enzymes (hampering drug metabolism), and ABC transporters (decreasing clearance). Reduced function of DNA repair enzymes may hamper effectiveness through dose-limiting toxicities. We investigated whether single-nucleotide polymorphisms (SNPs) were associated with breast cancer recurrence or mortality in premenopausal women diagnosed with breast cancer. METHODS: We conducted a population-based cohort study of premenopausal women diagnosed with non-distant metastatic breast cancer in Denmark during 2007‒2011, when guidelines recommended adjuvant combination chemotherapy (taxanes, anthracyclines, and cyclophosphamide). Using archived formalin-fixed paraffin-embedded primary tumor tissue, we genotyped 26 SNPs using TaqMan assays. Danish health registries provided data on breast cancer recurrence (through September 25, 2017) and death (through December 31, 2019). We fit Cox regression models to calculate crude hazard ratios (HRs) and 95% confidence intervals (CIs) for recurrence and mortality across genotypes. RESULTS: Among 2,262 women, 249 experienced recurrence (cumulative incidence: 13%) and 259 died (cumulative incidence: 16%) during follow-up (median 7.0 and 10.1 years, respectively). Mortality was increased in variant carriers of GSTP1 rs1138272 (HR: 1.30, 95% CI 0.95-1.78) and CYP3A rs10273424 (HR: 1.33, 95% CI 0.98-1.81). SLCO1B1 rs2306283 (encoding OATP1B1) variant carriers had decreased recurrence (HR: 0.82, 95% CI 0.64-1.07) and mortality (HR: 0.77, 95% CI 0.60-0.98). CONCLUSION: Docetaxel effectiveness was influenced by SNPs in GSTP1, CYP3A, and SLCO1B1 in premenopausal women with non-distant metastatic breast cancer, likely related to altered docetaxel pharmacokinetics. These SNPs may help determine individual benefit from taxane-based chemotherapy.

Optimized detection of germ cell neoplasia in situ in contralateral biopsy reduces the risk of second testis cancer.

OBJECTIVE: To evaluate whether optimized and standardized diagnostic procedures would improve detection of germ cell neoplasia in situ (GCNIS) in the contralateral testis of patients with testicular germ cell tumour (TGCT) and decrease the rate of metachronous tumours, which in a nationwide Danish study was estimated to be 1.9%. PATIENTS AND METHODS: This was a retrospective analysis of outcomes in 655 patients with TGCT who underwent contralateral biopsies (1996-2007) compared with those in 459 non-biopsied TGCT controls (1984-1988). The biopsies were performed using a standardized procedure with immunohistochemical GCNIS markers and assessed by experienced evaluators. Initial histopathology reports were reviewed, and pathology and survival data were retrieved from national Danish registers. In 604/608 patients diagnosed as GCNIS-negative (four were lost to follow-up), the cumulative incidence of metachronous TGCT was estimated in a competing risk setting using the Grey method. All cases of metachronous TGCT were re-examined using immunohistochemistry. RESULTS: Germ cell neoplasia in situ was found in 47/655 biopsied patients (7.2%, 95% confidence interval [CI] 5.4-9.5%). During the follow-up period (median 17.3 years) five of the 604 GCNIS-negative patients developed a TGCT. In 1/5 false-negative biopsies, GCNIS was found on histological revision using immunohistochemistry and 2/5 biopsies were inadequate because of too small size. The estimated cumulative incidence rate of second tumour after 20 years of follow-up was 0.95% (95% CI 0.10%-1.8%) compared with 2.9% (95% CI 1.3%-4.4%) among the non-biopsied TGCT patients (P = 0.012). The estimates should be viewed with caution due to the small number of patients with metachronous TGCT. CONCLUSIONS: Optimized diagnostic procedures improved the detection rate of GCNIS in patients with TGCT and minimized their risk of developing metachronous bilateral cancer. Urologists should be aware of the importance of careful tissue excision (to avoid mechanical compression) and the need of adequate biopsy size. Performing contralateral biopsies is beneficial for patients' care and should be offered as a part of their management.

Effects of football fitness training on lymphedema and upper-extremity function in women after treatment for breast cancer: a randomized trial.

BACKGROUND: Breast cancer survivors are encouraged to be physically active. A recent review suggests that football training is an effective exercise modality for women across the lifespan, positively influencing health variables such as strength, fitness and social well-being. However, football is a contact sport, potentially posing an increased risk of trauma-related injury. Against this backdrop, breast cancer survivors are advised to avoid trauma or injury to the affected or at-risk arm in order to protect against lymphedema onset or exacerbation. The aim of this study was therefore to evaluate the feasibility and safety of Football Fitness training in relation to lymphedema and upper-extremity function after treatment for breast cancer. MATERIAL AND METHODS: Sixty-eight women aged 18-75 years, who had received surgery for stage I-III breast cancer and completed (neo) adjuvant chemotherapy and/or radiotherapy within five years, were randomized (2:1) to a Football Fitness group (FFG, n = 46) or a control group (CON, n = 22) for twelve months. Secondary analyses using linear mixed models were performed to assess changes in upper-body morbidity, specifically arm lymphedema (inter-arm volume % difference, dual energy X-ray absorptiometry; extracellular fluid (L-Dex), bioimpedance spectroscopy), self-reported breast and arm symptoms (EORTC breast cancer-specific questionnaire (BR23) and upper-extremity function (DASH questionnaire) at baseline, six- and twelve-month follow-up. RESULTS: We observed similar point prevalent cases of lymphedema between groups at all time points, irrespective of measurement method. At the six-month post-baseline assessment, reductions in L-Dex (extracellular fluid) were found in FFG versus CON. These significant findings were not maintained at the twelve-month assessment. No difference between groups was observed for inter-limb volume difference %, nor any of the remaining outcomes. CONCLUSION: While superiority of Football Fitness was not observed, the results support that participation in Football Fitness training is feasible and suggests no negative effects on breast cancer-specific upper-body morbidity, including lymphedema. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov. NCT03284567.

Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post-authorization safety cohort study conducted in Europe and in the United States.

PURPOSE: We examined safety outcomes of interest (SOI) and overall survival (OS) among lung cancer patients initiating crizotinib and erlotinib in routine clinical practice. METHODS: This descriptive cohort study used routinely collected health data in Denmark, Finland, Sweden, the Netherlands, and the United States (US) during 2011-2017, following crizotinib commercial availability in each country. Among crizotinib or erlotinib initiators, we reported baseline characteristics and incidence rates and cumulative incidences of the SOI - hepatotoxicity, pneumonitis/interstitial lung disease, QT interval prolongation-related events, bradycardia, vision disorders, renal cysts, edema, leukopenia, neuropathy, photosensitivity, malignant melanoma, gastrointestinal perforation, cardiac failure and OS. Results from the European Union (EU) countries were combined using meta-analysis; results from the US were reported separately. RESULTS: There were 456 patients in the crizotinib cohort and 2957 patients in the erlotinib cohort. Rates of the SOI per 1000 person-years in the crizotinib cohort ranged from 0 to 65 in the EU and from 0 to 374 in the US. Rates of the SOI per 1000 person-years in the erlotinib cohort ranged from 0 to 91 in the EU and from 3 to 394 in the US. In the crizotinib cohort, 2-year OS was ~50% in both EU and US. In the erlotinib cohort, 2-year OS was 21% in the EU and 35% in the US. CONCLUSIONS: This study describes clinical outcomes among lung cancer patients initiating crizotinib or erlotinib in routine clinical practice. Differences between SOI rates in EU and US may be partially attributable to differences in the underlying databases.

One year of Football Fitness improves L1-L4 BMD, postural balance, and muscle strength in women treated for breast cancer.

PURPOSE: To examine efficacy of 12 months Football Fitness offered twice per week on bone mineral density (BMD), bone turnover markers (BTM), postural balance, muscle strength, and body composition in women treated for early-stage breast cancer (BC). METHODS: Women treated for early-stage BC were randomized to Football Fitness (FFG, n = 46) or control (CON, n = 22) in a 2:1 ratio for 12 months, with assessments performed at baseline, 6 months and 12 months. Outcomes were total body-, lumbar spine- and proximal femur BMD, total body lean and fat mass, leg muscle strength, postural balance, and plasma amino-terminal propeptide of type 1 procollagen (P1NP), osteocalcin, and C-terminal telopeptide of type 1 collagen (CTX). Intention-to-treat (ITT) analyses and per-protocol analyses (≥50% attendance in FFG) were performed using linear mixed models. RESULTS: Participants in FFG completing the 12-month intervention (n = 33) attended 0.8 (SD = 0.4) sessions per week. Intention to treat analysis of mean changes over 12 months showed significant differences (p<.05) in L1-L4 BMD (0.029 g/cm2 , 95%CI: 0.001 to 0.057), leg press strength (7.2 kg, 95%CI: 0.1 to 14.3), and postural balance (-4.3 n need of support, 95%CI: -8.0 to -0.7) favoring FFG compared to CON. In the per-protocol analyses, L1-L4 and trochanter major BMD were improved (p = .012 and .030, respectively) in FFG compared with CON. No differences were observed between groups in BTMs in the ITT or per protocol analyses. CONCLUSION: One year of Football Fitness training may improve L1-L4 BMD, leg muscle strength, and postural balance in women treated for early-stage breast cancer.

Cancer and risk of Alzheimer's disease: Small association in a nationwide cohort study.

INTRODUCTION: Small observational studies with short-term follow-up suggest that cancer patients are at reduced risk of Alzheimer's disease (AD) compared to the general population. METHODS: A nationwide cohort study using Danish population-based health registries (1980-2013) with cancer patients (n = 949,309) to identify incident diagnoses of AD. We computed absolute reductions in risk attributed to cancer and standardized incidence rate ratios (SIRs) accounting for survival time, comparing the observed to expected number of AD cases. RESULTS: During up to 34 years of follow-up of cancer survivors, the attributable risk reduction was 1.3 per 10,000 person-years, SIR = 0.94 (95% confidence interval 0.92-0.96). SIRs were similar after stratification by sex, age, and cancer stage, and approached that of the general population for those surviving >10 years. DISCUSSION: Inverse associations between cancer and AD were small and diminished over time. Incidence rates in cancer survivors approached those of the general population, suggesting limited association between cancer and AD risk.

Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial.

BACKGROUND: Physical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted. METHODS AND FINDINGS: We conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI -1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI -0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (-0.9 kg [95% CI -1.7 to -0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report. CONCLUSIONS: In this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football proved to be acceptable, even when club membership was not subsidised. TRIAL REGISTRATION: ClinicalTrials.gov NCT02430792.

Frozen shoulder and risk of cancer: a population-based cohort study.

BACKGROUND: Frozen shoulder might be a complication or a presenting symptom of cancer. We examined the risk of a cancer diagnosis after an incident diagnosis of frozen shoulder. METHODS: We used prospectively collected data from Danish registries to identify patients with frozen shoulder during 1995-2013 and followed them for the development of cancer. RESULTS: We observed 2572 incident cancers among 29 098 frozen shoulder patients. The expected number of incident cancers in the general population was 2434. The 6-month cumulative incidence of any cancer was 0.70%, corresponding to a standardised incidence ratio (SIR) of 1.38 (95% confidence interval (CI): 1.19-1.58). Risk increases were highest for lung cancer (SIR=2.19, 95% CI: 1.48-3.13), breast cancer (SIR=1.51, 95% CI: 1.02-2.15), and non-Hodgkin's lymphoma (SIR=2.28, 95% CI: 1.09-4.20). The cumulative incidence of any cancer during the remainder of follow-up (>6 months to a maximum 18.9 years) was 24.8% with an SIR of 1.04 (95% CI: 1.00-1.08). CONCLUSIONS: Frozen shoulder might be an early predictor for a subsequent cancer diagnosis.

Effectiveness of community-based football compared to usual care in men with prostate cancer: Protocol for a randomised, controlled, parallel group, multicenter superiority trial (The FC Prostate Community Trial).

BACKGROUND: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer. METHODS: Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy-Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period. DISCUSSION: Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02430792.

Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations.

PURPOSE: To investigate the activity profile of football training and its short-term effects on bone mass, bone turnover markers (BTMs) and postural balance in men with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). METHODS: This was a randomised 12-week study in which men with PCa undergoing ADT were assigned to a football intervention group [FTG, n = 29, 67 ± 7 (±SD) years] training 2‒3 times per week for 45‒60 min or to a control group (n = 28, 66 ± 5 years). The activity profile was measured using a 5-Hz GPS. The outcomes were total body and leg bone mineral content (BMC) and density, BTMs and postural balance. RESULTS: In the last part of the 12 weeks, FTG performed 194 ± 41 accelerations and 296 ± 65 decelerations at >0.6 m/s/s and covered a distance of 905 ± 297 m at speeds >6 km/h and 2646 ± 705 m per training session. Analysis of baseline-to-12-week change scores showed between-group differences in favour of FTG in total body BMC [26.4 g, 95 % confidence interval (CI): 5.8-46.9 g, p = 0.013], leg BMC (13.8 g, 95 % CI: 7.0‒20.5 g, p < 0.001) and markers of bone formation: P1NP (36.6 µg/L, 95 % CI: 10.4‒62.8 µg/L, p = 0.008) and osteocalcin (8.6 µg/L, 95 % CI: 3.3‒13.8 µg/L, p < 0.01). The number of decelerations correlated to the increase in leg BMC (r = 0.65, p = 0.012). No between-group differences were observed for the remaining outcomes. CONCLUSION: Football training involves numerous runs, accelerations and decelerations, which may be linked to marked increases in bone formation markers and preserved bone mass in middle-aged and elderly men with PCa undergoing ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01711892.

The coverage of influenza vaccination and predictors of influenza non-vaccination in Danish cancer patients: A nationwide register-based cohort study.

BACKGROUND: Influenza vaccination is recommended and provided free-of-charge to Danish citizens aged ≥65 years and to individuals with acquired immunodeficiency. We aimed to estimate influenza vaccination coverage and investigate predictors of influenza non-vaccination in Danish cancer patients. METHODS: A nationwide cohort study of all Danish citizens aged ≥18 years with an incident cancer diagnosis between 2002 and 2017. Using national registries, we assessed information on influenza vaccination and potential predictors of influenza non-vaccination. We estimated adjusted prevalence ratios (aPR) of influenza non-vaccination for patients aged <65 years and ≥65 years. RESULTS: We observed 269,863 patients during 840,876 influenza vaccination seasons. The influenza vaccination coverage was 14 % for cancer patients <65 years and 51 % for those ≥65 years. No influenza vaccination in the previous season was associated with non-vaccination in the current season (<65 years: aPR = 2.75, 95 %CI = 2.71-2.80; ≥65 years: aPR = 5.15, 95 %CI = 5.10-5.21). Haematological cancer patients receiving chemotherapy had lower vaccination prevalence compared with those not receiving chemotherapy. CONCLUSIONS: The influenza vaccination coverage was low among cancer patients. Influenza non-vaccination in the previous season was the strongest predictor of not receiving influenza vaccination in the current season. Haematological cancer patients on current chemotherapy had lower vaccination prevalence than those not currently receiving chemotherapy.

"EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients.

BACKGROUND: Lung cancer is the leading cause of cancer death in North America and Western Europe. Patients with lung cancer in general have reduced physical capacity, functional capacity, poor quality of life and increased levels of anxiety and depression. Intervention studies indicate that physical training can address these issues. However, there is a lack of decisive evidence regarding the effect of physical exercise in patients with advanced lung cancer. The aim of this study is to evaluate the effects of a twelve weeks, twice weekly program consisting of: supervised, structured training in a group of advanced lung cancer patients (cardiovascular and strength training, relaxation). METHODS/DESIGN: A randomized controlled trial will test the effects of the exercise intervention in 216 patients with advanced lung cancer (non-small cell lung cancer (NSCLC) stage IIIb-IV and small cell lung cancer (SCLC) extensive disease (ED)). Primary outcome is maximal oxygen uptake (VO2peak). Secondary outcomes are muscle strength (1RM), functional capacity (6MWD), lung capacity (Fev1) and patient reported outcome (including anxiety, depression (HADS) and quality of life (HRQOL)). DISCUSSION: The present randomized controlled study will provide data on the effectiveness of a supervised exercise intervention in patients receiving systemic therapy for advanced lung cancer. It is hoped that the intervention can improve physical capacity and functional level, during rehabilitation of cancer patients with complex symptom burden and help them to maintain independent function for as long as possible. TRIAL REGISTRATION: http://ClinicalTrials.gov, NCT01881906.

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial.

BACKGROUND: Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The 'Football Club (FC) Prostate' study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer. METHODS/DESIGN: Using a single-center randomized controlled design, 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6 months or more at The Copenhagen University Hospital will be enrolled on this trial. After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care. The soccer intervention will consist of 12 weeks of training 2-3 times/week for 45-60 min after which the assessment protocol will be repeated. Soccer training will then continue bi-weekly for an additional 20 weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects. The primary endpoint is changes in lean body mass from baseline to 12 weeks assessed by dual X-ray absorptiometry scan. Secondary endpoints include changes of cardiovascular, metabolic, and physical function parameters, as well as markers of bone metabolism and patient-reported outcomes. DISCUSSION: The FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT. The results may pave the way for innovative, community-based interventions in the approach to treating prostate cancer. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01711892.

Intracranial germ cell tumours. A review with special reference to endocrine manifestations.

EPIDEMIOLOGY: Intracranial germ cell tumours (icGCTs) represent 3-15% of primary paediatric intracranial neoplasms with a considerable geographical variation in incidence. Ninety percent of patients diagnosed with icGCTs are under 20 years of age. PATHOLOGY: Histologic characteristics and investigation of the tumour markers ß-human chorionic gonadotropin (ß-hCG) and alpha-fetoprotein (AFP) help define the different categories of icGCTs. The tumours are divided into two major groups called germinomas and non-germinomatous GCTs (NGGCTs). CLINICAL PRESENTATION: The clinical symptoms depend on the size and location of tumour in the brain, which is most commonly in the pineal or suprasellar region. Pineal GCTs often present with neurological symptoms because of their tendency to cause increased intracranial pressure. Suprasellar GCTs are often accompanied by endocrine abnormalities such as diabetes insipidus (DI), growth retardation and precocious or delayed puberty. DIAGNOSIS: A combination of clinical findings, endocrine and tumour marker evaluation, spinal fluid cytology, magnetic resonance imaging (MRI) and biopsy helps verifying the diagnosis of an icGCT. A summary of published data (n = 97) revealed that >90% of patients at diagnosis had at least one endocrine abnormality, DI being the most common (>80%). TREATMENT: Classification of tumour is important for choice of treatment and for prognosis. A combination of chemotherapy and radiotherapy is often used, since most icGCTs have a great sensitivity to these treatment modalities. CONCLUSION: Endocrine symptoms are very frequently appearing in patients with icGCTs and they can present long before neuroimaging verification of tumour is possible. It is of the outmost importance to have the diagnosis of icGCTs in mind when children, adolescents and young adults are presenting with endocrine irregularities, because most icGCTs are very sensitive to radiotherapy and chemotherapy, and early onset of treatment is important in order to minimize morbidity and mortality.

Demonstration and manifestation of self-determination and illness resistance--a qualitative study of long-term maintenance of physical activity in posttreatment cancer survivors.

OBJECTIVE: The aim of this study was to describe posttreatment cancer survivors' lived experience of long-term maintenance of physical activity (PA). METHODS: A qualitative, salutogenetic-oriented study was conducted based on four audiotaped, semistructured focus group interviews. Interviewee selection was carried out through purposeful sampling. Twenty-three cancer survivors (17 women and 6 men; median age 50 years, range 29-70) who were physically inactive prior to their diagnosis but who had been exercising regularly for a minimum of 18 months posttreatment participated in the study. The participants were recruited from The Copenhagen PACT Study that evaluated the effect of a one-year rehabilitation program (supervised exercise [weekly], expert lectures [trimonthly], in-group coaching [bimonthly] and individual coaching [3 × 1 h]). Data were analyzed by use of systematic condensation analysis inspired by Giorgi's descriptive phenomenological methodology (see Sketch of a psychological phenomenological method, in: Giorgi A (ed.), Phenomenology and Psychological Research, Duquesne University Press, Pittsburgh, 1985). RESULTS: The analysis revealed five categories, which were summarized into an overall sentence describing the essence of long-term PA maintenance in cancer survivors: demonstration and manifestation of self-determination and illness resistance. In sum, the participants described regular PA as a prerequisite for feeling and staying well and preserving and pursuing own potentials whereby PA maintenance becomes a goal in itself. CONCLUSIONS: This study indicates that cancer survivors' continued motivation for PA may be dependent on the fulfillment of a personal and conscious experience of being in the process of creating and living a comprehensible and meaningful life. Future theory-based interventions to encourage PA maintenance in cancer survivors could potentially benefit by integration of humanistic and existential psychology in addition to social cognitive theory and theory of planned behavior.

Identifying Valid Algorithms for Number of Lines of Anti-Neoplastic Therapy in the Danish National Patient Registry Among Patients with Advanced Ovarian, Gastric, Renal Cell, Urothelial, and Non-Small Cell Lung Cancer Attending a Danish University Hospital.

PURPOSE: To develop algorithms to identify number of lines of anti-neoplastic therapy per patient based on the Danish National Patient Registry (DNPR) and identify which algorithm has the highest percentage agreement with a reference standard of documentation in medical records. PATIENTS AND METHODS: We included 179 patients diagnosed between January 1, 2012, and December 31, 2016, with stage II, III, or IV urothelial cell carcinoma or stage III or IV epithelial ovarian cancer, gastric adenocarcinoma, renal cell carcinoma, or non-small cell lung cancer (NSCLC). We developed two algorithms for number of lines of anti-neoplastic therapy based on dates and treatment codes (eg, "treatment with cisplatin" or "cytostatic treatment") in the DNPR. First, to denote a change in line of therapy the "Time-based algorithm" used the number of days between consecutive administrations. Second, the "Drug-based algorithm" used information on drug names if available or the number of days between consecutive administrations if no drug names were specified. We calculated the percentage agreement between the algorithms setting the number of allowed days between consecutive administrations from 28 to 50 and the reference standard - information on anti-neoplastic therapy drugs abstracted from medical records and subsequently coded according to lines of anti-neoplastic therapy. RESULTS: For the "Time-based algorithm", the highest percentage agreement with the reference standard was found when using <45 days between consecutive administrations (67.6%; 95% CI: 60.1-73.8%). However, the percentage agreement was higher for the "Drug-based algorithm" using <45 days between consecutive administrations for registrations where the drug name was unspecified (90.5%; 95% CI: 85.0-93.7%). CONCLUSION: The algorithm for number of lines of anti-neoplastic therapy that had the highest percentage agreement with the reference standard (medical records) incorporated both registration of specific drug names and <45 days between consecutive administrations if the drug name was unspecified in routinely recorded data from DNPR.

Progressive resistance training and cancer testis (PROTRACT) - efficacy of resistance training on muscle function, morphology and inflammatory profile in testicular cancer patients undergoing chemotherapy: design of a randomized controlled trial.

BACKGROUND: Standard treatment for patients with disseminated germ cell tumors is combination chemotherapy with bleomycin, etoposide and cisplatin (BEP). This treatment is highly effective, but the majority of patients experience severe adverse effects during treatment and are at risk of developing considerable long-term morbidity, including second malignant neoplasms, cardiovascular disease, and pulmonary toxicity. One neglected side effect is the significant muscular fatigue mentioned by many patients with testicular cancer both during and after treatment. Very limited information exists concerning the patho-physiological effects of antineoplastic agents on skeletal muscle. The primary aim of this study is to investigate the effects of BEP-treatment on the skeletal musculature in testicular cancer patients, and to examine whether the expected treatment-induced muscular deterioration can be attenuated or even reversed by high intensity progressive resistance training (HIPRT). DESIGN/METHODS: The PROTRACT study is a randomized controlled trial in 30 testicular cancer patients undergoing three cycles of BEP chemotherapy. Participants will be randomized to either a 9-week HIPRT program (STR) initiated at the onset of treatment, or to standard care (UNT). 15 healthy matched control subjects (CON) will complete the same HIPRT program. All participants will take part in 3 assessment rounds (baseline, 9 wks, 21 wks) including muscle biopsies, maximum muscle strength tests, whole body DXA scan and blood samples. PRIMARY OUTCOME: mean fiber area and fiber type composition measured by histochemical analyses, satellite cells and levels of protein and mRNA expression of intracellular mediators of protein turnover. SECONDARY OUTCOMES: maximum muscle strength and muscle power measured by maximum voluntary contraction and leg-extensor-power tests, body composition assessed by DXA scan, and systemic inflammation analyzed by circulating inflammatory markers, lipid and glucose metabolism in blood samples. Health related Quality of Life (QoL) will be assessed by validated questionnaires (EORTC QLQ-C30, SF-36). DISCUSSION: This study investigates the muscular effects of antineoplastic agents in testicular cancer patients, and furthermore evaluates whether HIPRT has a positive influence on side effects related to chemotherapy. A more extensive knowledge of the interaction between cytotoxic-induced physiological impairment and exercise-induced improvement is imperative for the future development of optimal rehabilitation programs for cancer patients. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32132990.

The effect of honey-coated bandages compared with silver-coated bandages on treatment of malignant wounds-a randomized study.

Malignant wounds (MWs) occur in 5-10% of all cancer patients. Malodor and exudation are the most common side effects. The aim was to determine the influence of honey-coated compared with silver-coated bandages on treatment of MWs. Patients were randomly selected to enter either group A (honey-coated bandages) or group B (silver-coated bandages). Parameters were the following: wound size, cleanliness, malodor, exudation, and wound pain. Digital photographs, visual analog scales (VAS), and wound morphology registration were used for measurement at baseline and following the 4-week intervention. Sixty-nine patients with MWs and advanced cancer, aged 47-90 (median 65.6), were included. No statistically significant difference was noted between the groups with respect to wound size, degree of cleanliness, exudation, malodor, and wound pain. There was a median decrease in wound size of 15 cm² and 8 cm² in group A and B, respectively (p = 0.63). Based on post-intervention pooled data from the groups, improvement was seen in 62% of the participants with respect to wound size and in 58% (n = 69) with respect to cleanliness. The VAS score for malodor (p = 0.007) and exudation (p < 0.0001) improved significantly post-intervention. Patients with reduced wound size had a median survival time of 387 days compared with 134 days in patients with no wound reduction (p = 0.003). The use of honey-coated and silver-coated bandages improved the outcome of MWs. No differences were found between the two regimens. Both types of bandages are recommended for use by patients with MWs containing tumor debris and necrosis.

Exercise may reduce depression but not anxiety in self-referred cancer patients undergoing chemotherapy. Post-hoc analysis of data from the 'Body & Cancer' trial.

Abstract Background. The diagnosis and treatment of cancer may cause clinically significant and persistent psychological morbidity. The objective of this study was to determine the short-term effect of a six week exercise intervention on anxiety and depression in cancer patients undergoing chemotherapy (The 'Body & Cancer' trial). Methods. Two hundred and nine self-referred patients (52 males, 157 females, mean age 47 years) were randomised into an intervention group and a waiting-list control group. Anxiety and depression was measured by the Hospital Anxiety and Depression Scale. Results. At baseline, 23.5% and 11.5% of the population scored >8 on the HADS and were classified as suspicious or definite cases of anxiety and depression, respectively. Adjusted for baseline score, disease and demographic covariates the estimated intervention effect showed improvement at six weeks for depression of -0.7 points (95% confidence interval [CI] -1.27 to -0.14, p = 0.0153). No significant effect was seen on anxiety. Further subanalysis, including only suspicious or definite cases of depression, resulted in an estimated intervention effect of -2.53 points (95% CI, -0.64 to -0.42, p = 0.021). Conclusion. Anti-depressant effects could be caused by exercise in self-referred cancer patients undergoing chemotherapy. Dedicated trials and follow-up studies are needed to clarify the optimal duration and content of exercise interventions to meet the needs of clinically depressive or anxious patients.