Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): an open-label, parallel, randomized, phase 2 trial.

BACKGROUND: Cancer cachexia (CC) is a multifactorial process characterized by progressive weight loss, muscle mass, and fat tissue wasting, which adversely affects the quality of life and survival of patients with advanced stages of cancer. CC has a complex and multifactorial pathophysiology, and there is no established standard treatment. Therefore, it is often irreversible and a single treatment modality is unlikely to suppress its progression. We are conducting a randomized trial to investigate the efficacy and safety of a multimodal intervention compared to the best supportive care for patients who received palliative chemotherapy. METHODS: Patients with lung or gastrointestinal cancers undergoing palliative chemotherapy are eligible. Patients are randomized into a multimodal intervention care (MIC) arm versus a conventional palliative care (CPC) arm. MIC includes ibuprofen, omega-3-fatty acid, oral nutritional supplement, weekly physical, psychiatric assessment, nutritional counseling, and complementary and alternative medicine. CPC includes basic nutritional counseling and megestrol acetate as needed (i.e., anorexia ≥ grade 2). All interventions are performed for 12 weeks per subject. The co-primary outcomes are change (kg) in total lean body mass and handgrip strength (kg) from the baseline. A total of 112 patients will be assigned to the two arms (56 in each group). DISCUSSION: The purpose of this study is to evaluate the effect of MIC in preventing or alleviating CC in patients who underwent palliative chemotherapy. As there is no established single treatment for CC, it is expected that the results of this clinical trial will provide new insights to significantly improve the quality of life of patients with cancer. Considering the complex mechanisms of cachexia, the effect of MIC rather than a single specific drug is more promising. In this study, we did not overly restrict the type of cancer or chemotherapy. Therefore, we attempted to measure the effects of complex interventions while preserving clinical situations. Thus, it is expected that the results of this study can be applied effectively to real-world practice. TRIAL REGISTRATION: This clinical trial was registered in the Clinical Research Information Service (KCT0004967), Korean Clinical Trial Registry on April 27, 2020, and ClinicalTrial.gov (NCT04907864) on June 1, 2021.

A Nutrition Intervention Focused on Weight Management Through Lifestyle Improvements in Prediabetic Subjects.

We reported the cases in order to evaluate the effects of individualized nutrition interventions for enhancing self-management abilities of prediabetic subjects. We conducted four nutrition interventions for weight control in two subjects with high-risk of type 2 diabetes. The first subject was a 53-year-old housewife, and the second subject was a 46-year-old male office worker. The subjects visited the medical center 4 times during the study period, and the lifestyle interventions were advised by a clinical team comprised physicians, clinical dietitians, and nurses. In particular, nutrition intervention to achieve weight loss focused on enhancing motivation and problem-solving skills to improve self-management ability. As a result, both subjects achieved weight loss by the time of their last visits. These two case studies, which differed in terms of sex, occupation, and dietary habits showed the importance of individualized nutrition intervention and forming an intimate relationship based on trust centered on prediabetic subjects. In conclusion, systematic collaboration within the clinical team is necessary, and social infrastructure should be prepared to fully realize the benefits of a systematic intervention program.

Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian.

This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

Development of job standards for clinical nutrition therapy for dyslipidemia patients.

Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

2011 clinical practice guidelines for type 2 diabetes in Korea.

As in other countries, type 2 diabetes is major health concern in Korea. A dramatic increase in the prevalence of type 2 diabetes and its chronic complications has led to an increase in health costs and economic burdens. Early detection of high risk individuals, hidden diabetic patients, and improvement in the quality of care for the disease are the first steps to mitigate the increase in prevalence. The Committee of Clinical Practice Guidelines of the Korean Diabetes Association revised and updated the '3rd Clinical Practice Guidelines' at the end of 2010. In the guidelines, the committee recommended active screening of high risk individuals for early detection and added the hemoglobin A1c level to the diagnostic criteria for type 2 diabetes based on clinical studies performed in Korea. Furthermore, the committee members emphasized that integrating patient education and self-management is an essential part of care. The drug treatment algorithm based on the degree of hyperglycemia and patient characteristics were also updated.

A comparative study of diet in good and poor glycemic control groups in elderly patients with type 2 diabetes mellitus.

BACKGROUND: Identification of dietary patterns is important for glycemic management in elderly patients with type 2 diabetes mellitus (T2DM). METHODS: Elderly T2DM patients (> 65 years of age, n = 48) were categorized based on their concentration of glycated hemoglobin (HbA(1c)). Subjects with HbA(1c) levels below 7% were placed in the good control (GC) group and those with HbA(1c) levels equal to or above 8% were placed in the poor control (PC) group. Anthropometric data, blood parameters, and dietary intake records were compared between the groups. Statistical analysis included Student's t-test, chi-square test, and Pearson correlation coefficient test. RESULTS: Anthropometric data, including body mass index (24.7 ± 2.9 kg/m(2)), did not differ between the GC and PC groups. Significant abnormalities in blood glucose levels (P < 0.01), lean body mass (P < 0.01), and plasma protein and albumin levels (P < 0.05, P < 0.01) were found in the PC group. In contrast to the GC group, the PC group depended on carbohydrate (P = 0.014) rather than protein (P = 0.013) or fat (P = 0.005) as a major source of energy, and had a lower index of nutritional quality for nutrients such as protein (P = 0.001), and all vitamins and minerals (P < 0.001, 0.01, or 0.05 for individual nutrients), except vitamin C, in their usual diet. Negative correlations between HbA(1c) levels and protein (r = -0.338, P < 0.05) or fat (r = -0.385, P < 0.01) intakes were also found. CONCLUSIONS: Healthcare professionals should encourage elderly diabetic patients to consume a balanced diet to maintain good glycemic control.

Web-based comprehensive information system for self-management of diabetes mellitus.

BACKGROUND: The aim of this study is to evaluate the effect of a web-based comprehensive information system, consisting of Internet and cellular phone use, on blood glucose control. METHODS: We established eMOD (electronic Management of Diabetes), a web-based ubiquitous information system, for cell phone users along with a website for Internet users to provide diabetes education. We examined whether this information system has the same impact on glycemic control as conventional education for the diabetes patient. Forty volunteers were enrolled and randomly assigned to either the eMOD experimental group (n = 20) or the control group (n = 20). Blood glucose and glycated hemoglobin (A1C) levels were evaluated at baseline and after 6 months. RESULTS: The two groups were homogeneous in terms of age, sex, and diabetes' duration at baseline. A1C (from 9.0 +/- 2.3% to 7.5 +/- 1.4%, P = 0.031) and postprandial glucose level (228.1 +/- 79.7 to 173.5 +/- 50.2 mg/dL, P = 0.030) were significantly decreased over time in the intervention group but not in the control group. There was a significant relationship between the change in A1C and the frequency of access to the eMOD system via cellular phone (r = 0.766, P = 0.03; coefficient -0.147). CONCLUSIONS: A1C was improved by a web-based intervention not only via computer but also via cellular phone at 6 months post-initiation in patients with type 2 diabetes. These results indicate that the use of a convenient web-based education system could be more effective for glycemic control than traditional education for diabetes patients.