Guidance for assessment of the muscle mass phenotypic criterion for the Global Leadership Initiative on Malnutrition (GLIM) diagnosis of malnutrition.

The Global Leadership Initiative on Malnutrition (GLIM) provides consensus criteria for the diagnosis of malnutrition that can be widely applied. The GLIM approach is based on the assessment of three phenotypic (weight loss, low body mass index, and low skeletal muscle mass) and two etiologic (low food intake and presence of disease with systemic inflammation) criteria, with diagnosis confirmed by any combination of one phenotypic and one etiologic criterion fulfilled. Assessment of muscle mass is less commonly performed than other phenotypic malnutrition criteria, and its interpretation may be less straightforward, particularly in settings that lack access to skilled clinical nutrition practitioners and/or to body composition methodologies. In order to promote the widespread assessment of skeletal muscle mass as an integral part of the GLIM diagnosis of malnutrition, the GLIM consortium appointed a working group to provide consensus-based guidance on assessment of skeletal muscle mass. When such methods and skills are available, quantitative assessment of muscle mass should be measured or estimated using dual-energy x-ray absorptiometry, computerized tomography, or bioelectrical impedance analysis. For settings where these resources are not available, then the use of anthropometric measures and physical examination are also endorsed. Validated ethnic- and sex-specific cutoff values for each measurement and tool are recommended when available. Measurement of skeletal muscle function is not advised as surrogate measurement of muscle mass. However, once malnutrition is diagnosed, skeletal muscle function should be investigated as a relevant component of sarcopenia and for complete nutrition assessment of persons with malnutrition.

Definition and diagnostic criteria for sarcopenic obesity: ESPEN and EASO consensus statement.

INTRODUCTION: Loss of skeletal muscle mass and function (sarcopenia) is common in individuals with obesity due to metabolic changes associated with a sedentary lifestyle, adipose tissue derangements, comorbidities (acute and chronic diseases), and during the ageing process. Co-existence of excess adiposity and low muscle mass/function is referred to as sarcopenic obesity (SO), a condition increasingly recognized for its clinical and functional features that negatively influence important patient-centred outcomes. Effective prevention and treatment strategies for SO are urgently needed, but efforts are hampered by the lack of an universally established SO Definition and diagnostic criteria. Resulting inconsistencies in the literature also negatively affect the ability to define prevalence as well as clinical relevance of SO for negative health outcomes. AIMS AND METHODS: The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) launched an initiative to reach expert consensus on a Definition and diagnostic criteria for SO. The jointly appointed international expert panel proposes that SO is defined as the co-existence of excess adiposity and low muscle mass/function. The diagnosis of SO should be considered in at-risk individuals who screen positive for a co-occurring elevated body mass index or waist circumference, and markers of low skeletal muscle mass and function (risk factors, clinical symptoms, or validated questionnaires). Diagnostic procedures should initially include assessment of skeletal muscle function, followed by assessment of body composition where presence of excess adiposity and low skeletal muscle mass or related body compartments confirm the diagnosis of SO. Individuals with SO should be further stratified into Stage I in the absence of clinical complications, or Stage II if cases are associated with complications linked to altered body composition or skeletal muscle dysfunction. CONCLUSIONS: ESPEN and EASO, as well as the expert international panel, advocate that the proposed SO Definition and diagnostic criteria be implemented into routine clinical practice. The panel also encourages prospective studies in addition to secondary analysis of existing datasets, to study the predictive value, treatment efficacy, and clinical impact of this SO definition.

Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement.

INTRODUCTION: Loss of skeletal muscle mass and function (sarcopenia) is common in individuals with obesity due to metabolic changes associated with a sedentary lifestyle, adipose tissue derangements, comorbidities (acute and chronic diseases) and during the ageing process. Co-existence of excess adiposity and low muscle mass/function is referred to as sarcopenic obesity (SO), a condition increasingly recognized for its clinical and functional features that negatively influence important patient-centred outcomes. Effective prevention and treatment strategies for SO are urgently needed, but efforts are hampered by the lack of a universally established SO definition and diagnostic criteria. Resulting inconsistencies in the literature also negatively affect the ability to define prevalence as well as clinical relevance of SO for negative health outcomes. AIMS AND METHODS: The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) launched an initiative to reach expert consensus on a definition and diagnostic criteria for SO. The jointly appointed international expert panel proposes that SO is defined as the co-existence of excess adiposity and low muscle mass/function. The diagnosis of SO should be considered in at-risk individuals who screen positive for a co-occurring elevated body mass index or waist circumference, and markers of low skeletal muscle mass and function (risk factors, clinical symptoms, or validated questionnaires). Diagnostic procedures should initially include assessment of skeletal muscle function, followed by assessment of body composition where presence of excess adiposity and low skeletal muscle mass or related body compartments confirm the diagnosis of SO. Individuals with SO should be further stratified into stage I in the absence of clinical complications or stage II if cases are associated with complications linked to altered body composition or skeletal muscle dysfunction. CONCLUSIONS: ESPEN and EASO, as well as the expert international panel, advocate that the proposed SO definition and diagnostic criteria be implemented into routine clinical practice. The panel also encourages prospective studies in addition to secondary analysis of existing data sets, to study the predictive value, treatment efficacy and clinical impact of this SO definition.

A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in patients with cancer cachexia and low body mass index.

BACKGROUND: Cancer cachexia is a syndrome characterized by anorexia and decreased body weight. This study evaluated the efficacy and safety of anamorelin, an orally active, selective ghrelin receptor agonist, in patients with cancer cachexia and a low body mass index (BMI). METHODS: This multicenter, open-label, single-arm study enrolled Japanese patients with non-small cell lung cancer or gastrointestinal cancer with cancer cachexia (BMI < 20 kg/m2 , involuntary weight loss > 2% in the last 6 months, and anorexia). Patients were administered 100 mg of anamorelin once daily for up to 24 weeks. The primary end point was a composite clinical response (CCR) at 9 weeks, which was defined as an increase in body weight of ≥5% from the baseline, an increase of ≥2 points in the score of the 5-item Anorexia Symptom Scale of the Functional Assessment of Anorexia/Cachexia Therapy, and being alive. RESULTS: One hundred two patients were eligible and enrolled. The means and standard deviations for age and BMI were 71.0 ± 8.2 years and 17.47 ± 1.48 kg/m2 , respectively. The CCR rate at 9 weeks was 25.9% (95% confidence interval [CI], 18.3%-35.3%), which met the primary end point with a lower 95% CI exceeding the prespecified minimum of 8%. Improvements in body weight and anorexia were durable and were accompanied by improvements in patients' global impression of change for appetite/eating-related symptoms and overall condition. Adverse drug reactions occurred in 37 of 101 treated patients (36.6%), with the most common being glycosylated hemoglobin increases, constipation, and peripheral edema. CONCLUSIONS: Anamorelin improved body weight and anorexia-related symptoms in patients with cancer cachexia and a low BMI with durable efficacy and favorable safety and tolerability. LAY SUMMARY: Anamorelin is a drug that stimulates appetite and promotes weight gain. This clinical trial was aimed at determining its efficacy and safety in Japanese cancer patients with a low body mass index and cachexia, a syndrome associated with anorexia and weight loss. Anamorelin was found to improve body weight and anorexia-related symptoms in these patients, and these effects were durable for up to 24 weeks. Moreover, anamorelin was generally well tolerated. These findings suggest that anamorelin is a valuable treatment option for patients with cancer cachexia and a low body mass index.

ESPEN practical guideline: Clinical nutrition in surgery.

Early oral feeding is the preferred mode of nutrition for surgical patients. Avoidance of any nutritional therapy bears the risk of underfeeding during the postoperative course after major surgery. Considering that malnutrition and underfeeding are risk factors for postoperative complications, early enteral feeding is especially relevant for any surgical patient at nutritional risk, especially for those undergoing upper gastrointestinal surgery. The focus of this guideline is to cover both nutritional aspects of the Enhanced Recovery After Surgery (ERAS) concept and the special nutritional needs of patients undergoing major surgery, e.g. for cancer, and of those developing severe complications despite best perioperative care. From a metabolic and nutritional point of view, the key aspects of perioperative care include the integration of nutrition into the overall management of the patient, avoidance of long periods of preoperative fasting, re-establishment of oral feeding as early as possible after surgery, the start of nutritional therapy immediately if a nutritional risk becomes apparent, metabolic control e.g. of blood glucose, reduction of factors which exacerbate stress-related catabolism or impaired gastrointestinal function, minimized time on paralytic agents for ventilator management in the postoperative period, and early mobilization to facilitate protein synthesis and muscle function.

Avoiding the incompatibility of peripheral parenteral nutrition solution and midazolam injection for intravenous sedation.

OBJECTIVES: We have observed white turbidity when a midazolam injection is administered from a lateral tube during the administration of a peripheral parenteral nutrition (PPN) solution. The aim of the current study was to determine how to avoid compound changes when co-administering a midazolam injection and a PPN solution. METHODS: Midazolam solutions were prepared by diluting a midazolam injection with a 5% glucose intravenous infusion. We examined the formulation of the midazolam injection and a PPN solution at the concentrations used in a clinical setting for changes in appearance, pH, and midazolam content in test tubes and during administration conditions. RESULTS: With a 1/4.8 dilution of midazolam in undiluted solution, clouding occurred. A strong correlation was revealed between the midazolam content as measured through high-performance liquid chromatography and the mixture's midazolam concentration (R2=0.9918). The capture rate of midazolam infused with PPN solution was 91.0% at a 1/6 dilution, whereas it decreased to <90% at a 1/4.8 dilution. CONCLUSIONS: Our results suggest that the administration of a midazolam injection solution diluted by ≥6-fold with glucose solution or saline from a side tube during the administration of a PPN solution did not cause changes in composition.

[Nutritional Management in Cancer Chemotherapy Based on Pathophysiology of Sarcopenia].

There are 4 purposes in the nutritional management for cancer patient. At first, we had better perform the early metabolic recovery from several invasive damages by some cancer treatments. At second, we give some special nutritional management for improvement from cancer cachexia. At third, we consider palliative nutritional management to terminal cancer patients based on pathophysiology of cachexia, their life styles and ethics. Finally, we give the social nutritional management for keeping high quality of life through well eating until the end of life. The basic nutritional management for cancer patients is administration of adequate amount of energy, protein/amino acids and micronutrients with suitable rehabilitation in order to prevent sarcopenia and malnutrition. In this paper, we explained about the metabolic influences to normal tissues, especially skeletal muscle, during chemotherapy. Also we mentioned importance to prevent sarcopenia and malnutrition during cancer treatment especially chemotherapy. Additionally, we showed the new topic about assessment for malnutrition, such as GLIM criteria, which is the global nutritional assessment formula for malnutrition including weight loss, low BMI and reduce of muscle mass. Now, we can recommend to use the global nutritional assessment and nutritional therapies even for cancer patients.

Influence of muscle mass on the estimation of glomerular filtration rate in Japanese terminal cancer patients.

BACKGROUND: Estimated glomerular filtration rate (eGFR) based on serum cystatin C (Scys) is useful for patients with decreased muscle mass, but has been also reported to be affected by cancer. The usefulness of Scys in eGFR in terminal cancer patients with decreased muscle mass is unknown. Therefore, we analyzed appropriate eGFR formulae for terminal cancer patients. METHODS: Study design was a retrospective observational study. Based on creatinine height index (CHI), 184 terminal cancer patients were stratified into CHI ≥ 90% (normal muscle mass, 59 patients); CHI 60-89% (mildly to moderately decreased muscle mass, 64 patients); and CHI < 60% (severely decreased muscle mass, 61 patients) groups. Twenty-four-hour creatinine clearance was measured and converted to the glomerular filtration rate (GFR) as a renal function measure. To estimate GFR, various eGFR formulae for Japanese were used: eGFRScys, eGFRScr5 and eGFRScr3, eGFRaverage and eGFRScys-Scr, and eGFRCG, based on Scys, serum creatinine (Scr), Scys and Scr combined, and Cockcroft-Gault formula (CG), respectively. Errors between measured and estimated values of renal function were verified using mean prediction errors (ME). When a 95% confidence interval (CI) of ME included 0, the accuracy of the eGFR formula was graded as good. RESULTS: eGFRScys ME was 0.2 (95% CI lower limit - 3.7, upper limit 4.0) mL/min/1.73 m2 in CHI 60-89% group and 9.2 (6.1, 12.9) mL/min/1.73 m2 in CHI < 60% group. eGFRScys was most accurate among the eGFR formulae. CONCLUSIONS: eGFR based on Scys was demonstrated as useful in terminal cancer patients with decreased muscle mass.

Multicentric prospective study of effect of dietary intake on quality of life for patients with end-stage cancers.

OBJECTIVE: Impaired dietary intake (DI) contributes to deterioration of quality of life (QOL) in patients with end-stage diseases, including cancer, but the effects of DI on QOL specifically in terminal cancer has not been widely studied. Here, we evaluated the relationship between DI and QOL in patients with end-stage cancers. METHODS: We evaluated the energy amount of DI, performance status (PS) and QLQ-C15-PAL score of cancer patients with short prognoses in multicentre survey and analysed the parameters that influence QOL. RESULTS: We recruited 33 patients in this study. In univariate analysis, DI was significantly associated with PS (P=0.002, r=-0.531), physical functioning (P=0.003, r=-0.503), fatigue (P=0.038, r=-0.362), and appetite loss (P=0.004, r=-0.490). CONCLUSIONS: Improved DI could contribute to QOL of patients with end-stage cancers.

Interleukin-8 and clinical symptoms can be prognostic indicators for advanced cancer patients with cachexia.

OBJECTIVES: Prognostic prediction is a significant tool for selecting appropriate treatment in advanced cancer patients with cachexia, at a time when it is important to offer high-quality palliative care and improve quality of life until death. In this retrospective study, we investigated the prognostic potential of serum cytokine level and various clinical symptoms by analyzing the pathological conditions and metabolic dynamics of cachexia in advanced cancer patients. METHODS: One hundred and fifty-three advanced cancer patients who underwent palliative care and died at the Department of Surgery and Palliative Medicine, Fujita Health University Nanakuri Memorial Hospital between 1 January 2004 and 30 June 2007 were eligible for the study. We simultaneously assessed their blood factors and clinical symptoms at admission. All patients were divided into two groups according to median survival time to analyze the risk factors for prognosis. RESULTS: Multivariate analysis revealed the following independent prognostic factors: interleukin (IL)-8 (odds ratio [OR]=4.17, 95% confidence interval [CI]=1.52-11.41, p=0.002), general fatigue (OR=1.22, 95%CI=1.03-1.45, p=0.019), anorexia (OR=1.19, 95%CI=1.04-1.37, p=0.008), dyspnea (OR=1.19, 95%CI=1.02-1.38, p=0.024), depression (OR=1.28, 95%CI=1.11-1.47, p<0.001), nausea (OR=1.25, 95%CI=1.05-1.48, p=0.007), dry mouth (OR=1.19, 95%CI=1.01-1.40, p=0.032), and overall assessment score (OR=1.05, 95%CI=1.02-1.09, p<0.001). Patients with low IL-8 (<1.347 pg/ml) and low overall assessment score (<26) had significantly better prognosis (both p<0.0001). CONCLUSIONS: High IL-8 level and clinical symptoms can be prognostic indicators for advanced cancer patients with cachexia.

Clinical Effects of a Pectin-Containing Oligomeric Formula in Tube Feeding Patients: A Multicenter Randomized Clinical Trial.

BACKGROUND: A pectin-containing oligomeric formula (POF) is a unique type of enteral formula that transforms from a liquid to a gel after reacting with gastric acid. Reports on its clinical effects have been limited. The present study was conducted to examine and verify the clinical effects of POF. METHODS: The study subjects were 201 stable patients receiving intragastric tube feeding. They were randomized into 2 groups to receive either POF or a standard polymeric formula (SPF) as a control. The duration of observation was 1 week. Analyses were conducted for the incidence of predefined composite events, including diarrhea, defecation treatments, and other enteral nutrition (EN) management-related events. RESULTS: Composite events occurred in 15 of 98 patients in the POF group and 30 of 100 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.011). In particular, diarrhea occurred in 2 patients in the POF group and 13 patients in the SPF group, with a significantly lower incidence in the POF group compared with the SPF group (P = 0.003). CONCLUSIONS: The results of this study suggest that POF is less likely to cause EN-related events, especially diarrhea, than SPF is.

Critical appraisal of definitions and diagnostic criteria for sarcopenic obesity based on a systematic review.

BACKGROUND: Sarcopenic obesity is a clinical and functional condition characterized by the coexistence of excess fat mass and sarcopenia. Currently, different definitions of sarcopenic obesity exist and its diagnostic criteria and cut-offs are not universally established. Therefore, the prevalence and sensitivity of this condition for any disease risk prediction is affected significantly. AIM: This work was conducted under the auspices of the European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO). An international expert panel performed a systematic review as an initial step to analyze and summarize the available scientific literature on the definitions and the diagnostic criteria for sarcopenic obesity proposed and/or applied in human studies to date. METHODS: The present systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The search was conducted in April 2018 in three databases (PubMed, Scopus, Web of Science). Human studies conducted in both sexes, irrespective of ethnicity, and published from 2007 to 2018 were included; cohorts of individuals with obesity and acute or chronic conditions and treatments reported to negatively influence skeletal muscle mass and function independently of obesity were excluded from final analyses. The quality of the studies was evaluated using the Newcastle-Ottawa Scale (NOS) adapted for cross sectional studies. RESULTS: The electronic search retrieved 2335 papers of which 75 met the eligibility criteria. A marked heterogeneity in definitions and approaches to diagnose sarcopenic obesity was observed. This was mainly due to differences in the definitions of obesity and sarcopenia, in the methodologies used to assess body composition and physical function, and in the reference values for the variables that have been used (different cut-offs, interquartile analysis, diverse statistical stratification methods). This variability may be attributable, at least in part, to the availability of the methodologies in the different settings, to the variability in specialties and backgrounds of the researcher, and to the different settings (general population, clinical settings, etc.) where studies were performed. CONCLUSION: The results of the current work support the need for consensus proposals on: 1) definition of sarcopenic obesity; 2) diagnostic criteria both at the level of potential gold-standards and acceptable surrogates with wide clinical applicability, and with related cut-off values; 3) methodologies to be used in actions 1 and 2. First steps should be aimed at reaching consensus on plausible proposals that would need subsequent validation based on homogeneous studies and databases, possibly based on analyses of existing cohorts, to help define the prevalence of the condition, its clinical and functional relevance as well as most effective prevention and treatment strategies.

[Metabolic and Nutritional Management for Cancer Cachexia].

There are 4 purposes in the nutritional management for cancer patient. At first, we had better perform the early metabolic recovery from several invasive damages by some cancer treatments. At second, we give some special nutritional management for improvement from cancer cachexia. At third, we consider palliative nutritional management to terminal cancer patients based on pathophysiology of cachexia, their life styles and ethics. Finally, we give the social nutritional management for keeping high quality of life through well eating until the end of life. In this paper, we explained about the metabolic influences to normal tissues during cancer treatments such as surgical operation, chemotherapy and radiotherapy. The mechanism and pathophysiology of cancer cachexia due to tumor expanding and metabolic disorders could be clear by our experimental results and other literatures. Also the nutritional management and metabolic regulation to control of symptoms and development of cachexia could be shown with prevention of sarcopenia. Administration of protein and amino acids, especially, branched chain amino acids, and some other micro nutrients should be useful for prevention of sarcopenia and cachexia. However, 3-4 weeks before death, the energy expenditure should decrease at the stage of refractory cachexia. Thus, in this point, we can recommend to reduce the total mounts of energy and solution at the nutritional management without overloading.

A multicenter, open-label, single-arm study of anamorelin (ONO-7643) in advanced gastrointestinal cancer patients with cancer cachexia.

BACKGROUND: Cancer cachexia is characterized by weight loss and is associated with increased morbidity and mortality in patients with cancer. Anamorelin (ONO-7643; ANAM) is a novel and selective ghrelin receptor agonist that improves appetite, lean body mass (LBM), body weight, and anorexia. METHODS: This multicenter, open-label, single-arm study investigated the efficacy and safety of 100 mg anamorelin in 50 Japanese patients with advanced and unresectable gastrointestinal (colorectal, gastric, or pancreatic) cancer. ANAM was administered once daily over 12 weeks. The primary endpoint was the proportion of patients that maintained or gained LBM over the course of the study. Secondary endpoints included changes in LBM, body weight, quality of life (QoL), and nutritional status biomarkers. RESULTS: The proportion of patients who responded to treatment was 63.3% (95% CI, 48.3%-76.6%), with a least square mean ± SE change in LBM and body weight from baseline of 1.89 ± 0.36 kg and 1.41 ± 0.61 kg, respectively. Appetite-related questions on the QoL questionnaire showed that ANAM improved appetite. Adverse events occurred in 79.6% of patients, and the most common treatment-related adverse events were increased γ-glutamyl transpeptidase (8.2%), diabetes mellitus (6.1%), hyperglycemia (6.1%), and prolonged QRS complex (6.1%). CONCLUSIONS: ANAM improved anorexia and patients' nutritional status, resulting in rapid increases in LBM and body weight in patients with advanced gastrointestinal cancer who had cancer cachexia. ANAM treatment was well tolerated over 12 weeks. ANAM is a potential clinically beneficial pharmacotherapeutic option for patients with advanced gastrointestinal cancer who have cancer cachexia.

A randomized phase II study of nutritional and exercise treatment for elderly patients with advanced non-small cell lung or pancreatic cancer: the NEXTAC-TWO study protocol.

BACKGROUND: Most advanced elderly cancer patients experience fatigue, anorexia, and declining physical function due to cancer cachexia, for which effective interventions have not been established. We performed a phase I study of a new nonpharmacological multimodal intervention called the nutritional and exercise treatment for advanced cancer (NEXTAC) program and reported the excellent feasibility of and compliance with this program in elderly patients with advanced cancer who were at risk for cancer cachexia. We report here the background, hypothesis, and design of the next-step multicenter, randomized phase II study to evaluate the efficacy of the program, the NEXTAC-TWO study. METHODS: Patients with chemo-naïve advanced non-small cell lung cancer or pancreatic cancer, age ≥ 70 years, performance status ≤2, with adequate organ function and without disability according to the modified Katz index will be eligible. In total, 130 participants will be recruited from 15 Japanese institutions and will be randomized into either the intervention group or a control group. Computer-generated random numbers are allocated to each participant. Stratification factors include performance status (0 to 1 vs. 2), site of primary cancer (lung vs. pancreas), stage (III vs. IV), and type of chemotherapy (cytotoxic vs. others). Interventions and assessment will be performed 4 times every 4 ± 2 weeks from the date of randomization. Interventions will consist of nutritional counseling, nutritional supplements (rich in branched-chain amino acids), and a home-based exercise program. The exercise program will include low-intensity daily muscle training and lifestyle education to promote physical activity. The primary endpoint is disability-free survival. It is defined as the period from the date of randomization to the date of developing disability or death due to any cause. This trial also plans to evaluate the improvements in nutritional status, physical condition, quality of life, activities of daily living, overall survival, and safety as secondary endpoints. Enrollment began in August 2017. The study results will demonstrate the efficacy of multimodal interventions for elderly cancer patients and their application for the maintenance of physical and nutritional conditions in patients with cancer cachexia. This work is supported by a grant-in-aid from the Japan Agency for Medical Research and Development. DISCUSSION: This is the first randomized trial to evaluate the efficacy and safety of a multimodal intervention specific for elderly patients with advanced cancer. TRIAL REGISTRATION: Registered at August 23, 2017. Registry number: UMIN000028801 .

Greater Nutrient Intake Is Associated With Lower Mortality in Western and Eastern Critically Ill Patients With Low BMI: A Multicenter, Multinational Observational Study.

BACKGROUND: Little is known about the impact of feeding adequacy by NUTrition Risk in the Critically Ill (NUTRIC) groups in critically ill patients with body mass index (BMI) <20. Our purpose was to assess whether adequacy of protein/energy intake impacts mortality in patients with BMI <20 in Western/Eastern intensive care units (ICUs) and high/low NUTRIC groups. METHODS: Data from the International Nutrition Survey 2013-2014 were dichotomized into Western/Eastern ICU settings; BMI <20 or ≥20; and high (≥5)/low (<5) NUTRIC groups. Association of BMI <20 with 60-day mortality was compared in unadjusted and adjusted (Western/Eastern, age, medical/surgical admission, high/low NUTRIC group) logistic regression models. The impact of adequacy of protein/energy on 60-day mortality relationship was tested using general estimating equations in high/low NUTRIC groups, in unadjusted and adjusted models. RESULTS: Western (n = 4274) patients had higher mean BMI (27.9 ± 7.7 versus (vs) 23.4 ± 4.9, P < 0.0001) than Eastern (n = 1375), respectively. BMI <20 was associated with greater mortality (adjusted odds ratio [OR] 1.30, 95% confidence interval [CI] 1.07-1.57), with no interaction between BMI group and Western/Eastern ICU site. Among patients with BMI <20 and high NUTRIC score, 10% greater protein and energy adequacy was associated with 5.7% and 5.5% reduction in 60-day mortality, respectively. Results were not significantly different between Western and Eastern ICUs. CONCLUSIONS: The benefit of greater protein/energy intake in high-NUTRIC patients was observed regardless of geographic origin or low BMI, suggesting a consistent response to nutrition support in this group. Clinical guidelines and research projects focused on improving care in high-risk critically ill patients can be applied across geographic boundaries.

Feasibility of early multimodal interventions for elderly patients with advanced pancreatic and non-small-cell lung cancer.

BACKGROUND: Combinations of exercise and nutritional interventions might improve the functional prognosis for cachectic cancer patients. However, high attrition and poor compliance with interventions limit their efficacy. We aimed to test the feasibility of the early induction of new multimodal interventions specific for elderly patients with advanced cancer Nutrition and Exercise Treatment for Advanced Cancer (NEXTAC) programme. METHODS: This was a multicentre prospective single-arm study. We recruited 30 of 46 screened patients aged ≥70 years scheduled to receive first-line chemotherapy for newly diagnosed, advanced pancreatic, or non-small-cell lung cancer. Physical activity was measured using pedometers/accelerometer (Lifecorder® , Suzuken Co., Ltd., Japan). An 8 week educational intervention comprised three exercise and three nutritional sessions. The exercise interventions combined home-based low-intensity resistance training and counselling to promote physical activity. Nutritional interventions included standard nutritional counselling and instruction on how to manage symptoms that interfere with patient's appetite and oral intake. Supplements rich in branched-chain amino acids (Inner Power® , Otsuka Pharmaceutical Co., Ltd., Japan) were provided. The primary endpoint of the study was feasibility, which was defined as the proportion of patients attending ≥4 of six sessions. Secondary endpoints included compliance and safety. RESULTS: The median patient age was 75 years (range, 70-84). Twelve patients (40%) were cachectic at baseline. Twenty-nine patients attended ≥4 of the six planned sessions (96.7%, 95% confidence interval, 83.3 to 99.4). One patient dropped out due to deteriorating health status. The median proportion of days of compliance with supplement consumption and exercise performance were 99% and 91%, respectively. Adverse events possibly related to the NEXTAC programme were observed in five patients and included muscle pain (Grade 1 in two patients), arthralgia (Grade 1 in one patient), dyspnoea on exertion (Grade 1 in one patient), and plantar aponeurositis (Grade 1 in one patient). CONCLUSIONS: The early induction of multimodal interventions showed excellent compliance and safety in elderly patients with newly diagnosed pancreatic and non-small-cell lung cancer receiving concurrent chemotherapy. We are now conducting a randomized phase II study to measure the impact of these interventions on functional prognosis.

GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community.

BACKGROUND: This initiative aims to build a global consensus around core diagnostic criteria for malnutrition in adults in clinical settings. METHODS: The Global Leadership Initiative on Malnutrition (GLIM) was convened by several of the major global clinical nutrition societies. Empirical consensus was reached through a series of face-to-face meetings, telephone conferences, and e-mail communications. RESULTS: A 2-step approach for the malnutrition diagnosis was selected, that is, first screening to identify at risk status by the use of any validated screening tool, and second, assessment for diagnosis and grading the severity of malnutrition. The malnutrition criteria for consideration were retrieved from existing approaches for screening and assessment. Potential criteria were subjected to a ballot among GLIM participants that selected 3 phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and 2 etiologic criteria (reduced food intake or assimilation, and inflammation or disease burden). To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present. Phenotypic metrics for grading severity are proposed. It is recommended that the etiologic criteria be used to guide intervention and anticipated outcomes. The recommended approach supports classification of malnutrition into four etiology-related diagnosis categories. CONCLUSIONS: A consensus scheme for diagnosing malnutrition in adults in clinical settings on a global scale is proposed. Next steps are to secure endorsements from leading nutrition professional societies, to identify overlaps with syndromes like cachexia and sarcopenia, and to promote dissemination, validation studies, and feedback. The construct should be re-considered every 3-5 years.

Molecular-targeted therapy for advanced anaplastic thyroid cancer combined with nutritional support.

Management of anaplastic thyroid cancer (ATC) is often difficult because of its aggressive characteristics. Molecular-targeted therapy was recently introduced as an alternative therapeutic strategy for ATC; lenvatinib is a molecular-targeted agent that is currently indicated only in Japan for the treatment of ATC. Here we report the case of an 86-year-old Japanese woman with ATC who was treated with lenvatinib at our hospital and exhibited a remarkable response. Computed tomography showed tumor shrinkage by day 8 and stable disease until day 32. She maintained activities of daily living (ADLs) until shortly before her death. The patient's resting energy expenditure and body composition were analyzed at the time of admission. Potential toxicity risk of lenvatinib was evaluated based on these data. Enteral nutrition for oral intake was supplied to compensate for her lack of dietary intake and to improve metabolism for the purpose of suppressing lenvatinib toxicity. She also engaged in physical rehabilitation to avoid developing sarcopenia, which is thought to be a risk factor of molecular-targeted therapy toxicity, and to maintain her activity level. We emphasize the importance of a team approach for providing an appropriate treatment regimen to maintain ADLs, which includes nutritional support, physical rehabilitation, and aggressive therapy with lenvatinib.

Feasibility of International Proposed Standardized Enteral Connector for Semi-Solid Formula Feeding.

BACKGROUND/AIMS: The current study was undertaken to assess if the semi-solid formulas could be used with a new ENFit connector with similar force to current percutaneous endoscopic gastrostomy (PEG) tubes. METHODS: Experiment 1: We measured the applied pressure (force) needed to compress the syringe containing 7 viscous semi-solid formulas with a 20 Fr PEG tube and low-profile tube through the ENFit connector or the current connector. Experiment 2: This experiment was conducted to evaluate the compression force through 2 connectors in 3 infusion velocity, 7 PEG tube types with 2 semi-solid formulas. RESULTS: Experiment 1: The force needed to compress the syringe through the ENFit connector was higher in 3 semi-solid formulas with a 20 Fr low-profile tube; otherwise, there were no significant differences. Experiment 2: Each formula required a higher force in the ENFit connector in 6 settings out of 21. CONCLUSIONS: The ENFit connector will likely not show any remarkable change in the force to administer the semi-solid formula. However, a higher force was required under some conditions in the prototype ENFit connector. Further investigation of sensory test is needed to confirm the feasibility of the ENFit connector for using the semi-solid formulas.