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.

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.

[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.

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 .

[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.

Implementation of Intravenous Drip Infusion Therapy with Peripheral Venous Catheters and the Incidence of Related Complications in Home-Based Medical Care Settings in Japan.

BACKGROUND/AIMS: Home-based medical care is rapidly expanding in Japanese health care settings. We aimed to clarify the implementation status of drip injection with peripheral venous catheters (PVCs) and the incidence of related complications. METHODS: We investigated the number of patients who required intravenous drip infusion therapy at home. We also examined the incidence rate of PVC-related complications and their statistical correlation with patients' characteristics. RESULTS: Of 139 patients, 30 (21.6%) received intravenous drip infusion therapy through PVCs at home. Patients' activities of daily living (bed-ridden) and the presence of underlying disease (terminal cancer) were significantly correlated with the requirement for drip infusion therapy (p < 0.0001 and p < 0.0001, respectively). A high incidence of PVC-related complications (75%: 15 out of 20 patients) was observed. More than 50% of patients experienced multiple needling due to difficulty in securing venous access. CONCLUSIONS: This is the first report to reveal the relatively high incidence of PVC-related complications in home-based medical care settings. Safer vascular devises should be incorporated for more stable intervention.

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.

Effects of Combined Treatment with Branched-Chain Amino Acids, Citric Acid, L-Carnitine, Coenzyme Q10, Zinc, and Various Vitamins in Tumor-Bearing Mice.

A functional dietary supplement (FDS) containing Coenzyme Q10, branched-chain amino acids and L-carnitine was administered to tumor-bearing mice, investigating its effects on tumor and muscle tissues. Experiment (A): B16 melanoma cells were implanted subcutaneously into the right side of the abdomen of 8- to 9-week-old C57BL/6J mice. The mice were divided into two groups: a FDS group that received oral administration of FDS (n=10), and a control group that received oral administration of glucose (n=10). The moribund condition was used as the endpoint, and median survival time was determined. Experiment (B): On day 21 after tumor implantation, tumors, soleus muscle, gastrocnemius muscle, and suprahyoid muscles were collected. Tumor and muscle weight and other aspects were evaluated in each group: FDS group (n=15) and control group (n=15). The median survival time was comparable (21 d in the FDS group vs. 18 d in the control group, p=0.30). However, cumulative food intake was significantly higher in the FDS group than the control group (p=0.011). Metastasis of melanoma to the lung was observed in the control group but not in the FDS group (p=0.043). The weight of the suprahyoid muscles was significantly higher in the FDS group than in the control group (p=0.0045). The weight of the tumor was significantly lower in the FDS group than in the control group (p=0.013). The results possibly suggest oral administration of FDS in tumor-bearing mice enhances the maintenance of suprahyoid muscles, resulting in an extended feeding period and suppression of tumor growth and metastasis.

A Clinical Study on Administration of Opioid Antagonists in Terminal Cancer Patients: 7 Patients Receiving Opioid Antagonists Following Opioids among 2443 Terminal Cancer Patients Receiving Opioids.

There have been few detailed reports on respiratory depression due to overdoses of opioids in terminal cancer patients. We investigated the situation of treatment with opioid antagonists for respiratory depression that occurred after administration of opioid at optimal doses in terminal cancer patients, to clarify pathological changes as well as causative factors. In 2443 terminal cancer patients receiving opioids, 7 patients (0.3%) received opioid antagonists: 6, morphine (hydrochloride, 5; sulfate, 1); 1, oxycodone. The median dosage of opioids was 13.3 mg/d, as converted to morphine injection. Respiratory depression occurred on this daily dose in 4 patients and after changed dose and route in 3 patients. Opioids were given through the vein in 6 patients and by the enteral route in 1 patient. Concomitant drugs included nonsteroidal anti-inflammatory drugs in 3 patients and zoledronic acid in 2 patients. In morphine-receiving patients, renal functions were significantly worsened at the time of administration of an opioid antagonist than the day before the start of opioid administration. These findings indicate that the proper use of opioids was safe and acceptable in almost all terminal cancer patients. In rare cases, however, a risk toward respiratory depression onset is indicated because morphine and morphine-6-glucuronide become relatively excessive owing to systemic debility due to disease progression, especially respiratory and renal dysfunctions. At the onset of respiratory depression, appropriate administration of an opioid antagonist mitigated the symptoms. Thereafter, opioid switching or continuous administration at reduced dosages of the same opioids prevented the occurrence of serious adverse events.

Efficacy of a New Post-Mouthwash Intervention (Wiping Plus Oral Nutritional Supplements) for Preventing Aspiration Pneumonia in Elderly People: A Multicenter, Randomized, Comparative Trial.

BACKGROUND/AIMS: Aspiration pneumonia is a common cause of death among the elderly (≥90-year-old) in nursing homes. Studies suggest that its incidence could be reduced by oral care interventions. We aimed to evaluate the efficacy of a new oral care intervention: wiping plus oral nutritional supplements (ONS). METHODS: This prospective observational study was conducted in 252 patients (age 88.0 ± 6.5 years) in 75 nursing homes, rehabilitation hospitals, and other care facilities. Patients were randomly divided into an intervention group (n = 74) and a control group (n = 107), whose members received conventional oral care. Body mass index, activities of daily living (Barthel index), and complete blood count and biochemistry parameters were measured at 2, 4, 6, and 8 months. RESULTS: The cumulative incidence of pneumonia at 8 months tended to be lower in the intervention than in the control group (7.8 vs. 17.7%, p = 0.056) and was significantly lower for men in the intervention group (p = 0.046). CONCLUSIONS: Our new intervention "wiping plus providing ONS" method appears to help prevent aspiration pneumonia, thereby reducing mortality risk. In this study, we disseminate information on how this method is used in Japan.

Guidelines for parenteral fluid management for terminal cancer patients.

BACKGROUND: Japan's first guidelines for parenteral fluid management for terminal cancer patients were issued in 2006. These guidelines focused on the fluid levels to administer to patients with a remaining life expectancy of 1-2 months. However, recent refinement of the concept of cachexia is prompting caregivers worldwide to rethink parenteral fluid management for terminal cancer patients. OBJECTIVE: Our objective was to develop guidelines for parenteral fluid management for terminal cancer patients with a remaining life expectancy of 1 month, a point when cachexia generally begins to severely adversely affect the body. METHODS: The Japanese Society for Palliative Medicine appointed a Guidelines Working Practitioner Group consisting of a multidisciplinary team of specialists. In response to 26 clinical questions on parenteral fluid management for terminal cancer patients, the Working Group used the Delphi method to reach consensus on the recommendability and evidence level of 89 relevant manuscripts identified through a systematic literature review. The Working Group then had an outside committee reviews the draft guidelines validity before authoring the final version. RESULTS: The resulting clinically aligned guidelines contain specific recommendations (25 recommendations on physical suffering/remaining life expectancy, 10 nursing-related recommendations and 4 ethical recommendations) assessed using the Delphi method and by an outside committee. CONCLUSIONS: Japanese Society for Palliative Medicine released a revised edition of the Guidelines for Parenteral Fluid Management for Terminal Cancer Patients, which are based on medical evidence and consider the pathologic features of cachexia. We recommend that caregivers carefully evaluate the clinical usefulness of the guidelines.

[EFFECTIVENESS OF NUTRITION SUPPORT TEAMS AND FUTURE OUTLOOK IN AN AGING SOCIETY].

Nutritional management is a type of basic therapy common to the treatment of all diseases. Appropriate nutritional management in response to the needs of individual patients is called nutrition support, and an interdisciplinary group performing this function is called a nutrition support team (NST). The NST concept began with the development of total parenteral nutrition in 1968, although it did not immediately spread to Japan. In 1998, the potluck party method, a uniquely Japanese administrative system, was proposed, and NSTs were established in facilities throughout the country. In 2001, the Japanese Society for Parenteral and Enteral Nutrition planned the NST Project to support the establishment of NSTs under societal guidance. From 2006, the basic activities of NSTs in hospitals have been covered by healthcare fees. By 2010, the full range of activity of NSTs had been recognized as a necessary medical service in Japan with its aging population, and total medical fees for NST activities were covered by the social insurance system. By the end of 2014, NSTs had been established in more than 1,480 facilities nationwide. NSTs are now recognized as one of the most important medical tools available, including their social nutrition activities. Therefore, NSTs are expected to have increasing therapeutic usefulness in Japanese society with its growing proportion of elderly residents.

[Cancer and Malnutrition].

A Japanese proverb says that a balanced diet leads to a healthy body. However, the relation between healthy life and nutrition has not been established precisely and quantitatively. Cancer cachexia, which is malnutrition in cancer patients, has been studied extensively. Appropriate nutrition support can prevent the progression of malnutrition in cancer patients and advance the tolerance for anticancer therapy. In refractory cachexia (terminally cancer patients), we will judge the necessity of reduction of nutrition support, what it is called "gear-change", because the support is burden for the body. It is important to restrict the quantity of nutrition and to give medical treatment to retain bodily function in these patients.

Influence of serum albumin levels during opioid rotation from morphine or oxycodone to fentanyl for cancer pain.

Morphine, oxycodone, and fentanyl are commonly used to control cancer pain. Because these drugs have differences in receptor affinity or pharmacokinetic parameters, changing the opioid formulation may result in an unexpected outcome, depending on the patient's condition. This study investigated whether low serum protein levels influence the effectiveness of opioid rotation by determining the impact of serum albumin levels on the analgesic effect before and after opioid rotation from morphine or oxycodone to fentanyl in cancer patients. The patients were classified into 3 groups according to their serum albumin levels before opioid rotation: group 1, <2.5 g/dL; group 2, from 2.5 g/dL to <3.0 g/dL; and group 3, ≥3.0 g/dL. There was no significant change in the percentage of patients with good pain control after rotation in group 1 or group 2; however, the percentage of patients with good pain control increased significantly in group 3. When the percentage of patients whose numerical rating scale scores increased, were unchanged, or decreased after rotation were compared, a significant difference in the percentage of those showing improvement was noted among the 3 groups and between groups 1 and 3. These findings suggest that monitoring serum albumin levels during fentanyl therapy is useful for pain management, and that the effectiveness of opioid rotation to fentanyl in patients with serum albumin levels of <2.5 g/dL should be carefully evaluated after rotation.

[A case of gastric cancer with peritoneal dissemination and massive ascites successfully treated with S-1/docetaxel therapy].

A 49-year-old woman who complained of abdominal bloating and numbness in the bilateral lower limbs was diagnosed as advanced scirrhous gastric cancer with massive ascites. The biopsy specimen showed a poorly-differentiated adenocarcinoma. She was therefore treated with combined chemotherapy of tri-weekly docetaxel(40mg/m2, day 1, 22)and S-1(60mg/m2, day 1-14 with 1-week rest)for unresectable gastric cancer. After 5 courses, computed tomography showed no ascites. Furthermore, after 31 courses, the loss of ascites continued, and the thickening of the stomach walls was reduced. These findings suggested that a complete response in terms of Evaluation Criteria in Solid Tumors(RECIST)was obtained. The side effects throughout chemotherapy were Grade I anemia and Grade I alopecia. Docetaxel and S-1 chemotherapy may well be one of the effective treatments for advanced scirrhous gastric cancer.

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.

[Cancer patient therapy and nutritional support].

For clinical treatment of cancer patients, surgical operation, chemotherapy, radiotherapy, immunotherapy and palliative care are available. Among these therapies, the main radical treatments such as surgical operation, chemotherapy and radiotherapy provide patients with anti-cancer-effects, but also cause unwanted invasive influences to normal tissues. Nutritional support is essential for cancer patients because it helps reduce these invasive influences and promotes recovery of damaged non-cancer tissues. Nutritional support for cancer patients receiving any anti-cancer therapies helps decrease the degree of invasion to non-cancer tissues and healthy body functions, helps with the promotion of reproduction and recovery of injured tissues and functions, normalizes metabolic disturbances by anti-cancer therapies, improves malnutrition based by side effects of invasive treatments, promotes immune-function using immune-nutrients, and offers nutritional care for patients at the terminal stage by assisting in metabolic conditioning for patients with cancer cachexia.