The effects of a family-centered psychosocial-based nutrition intervention in patients with advanced cancer: the PiCNIC2 pilot randomised controlled trial.

BACKGROUND: Malnutrition in advanced cancer patients is common but limited and inconclusive data exists on the effectiveness of nutrition interventions. Feasibility and acceptability of a novel family-based nutritional psychosocial intervention were established recently. The aims of this present study were to assess the feasibility of undertaking a randomised controlled trial of the latter intervention, to pilot test outcome measures and to explore preliminary outcomes. METHODS: Pilot randomised controlled trial recruiting advanced cancer patients and family caregivers in Australia and Hong Kong. Participants were randomised and assigned to one of two groups, either a family-centered nutritional intervention or the control group receiving usual care only. The intervention provided 2-3 h of direct dietitian contact time with patients and family members over a 4-6-week period. During the intervention, issues with nutrition impact symptoms and food or eating-related psychosocial concerns were addressed through nutrition counselling, with a focus on improving nutrition-related communication between the dyads and setting nutritional goals. Feasibility assessment included recruitment, consent rate, retention rate, and acceptability of assessment tools. Validated nutritional and quality of life self-reported measures were used to collect patient and caregiver outcome data, including the 3-day food diary, the Patient-Generated Subjective Global Assessment Short Form, the Functional Assessment Anorexia/Cachexia scale, Eating-related Distress or Enjoyment, and measures of self-efficacy, carers' distress, anxiety and depression. RESULTS: Seventy-four patients and 54 family caregivers participated in the study. Recruitment was challenging, and for every patient agreeing to participate, 14-31 patients had to be screened. The consent rate was 44% in patients and 55% in caregivers. Only half the participants completed the trial's final assessment. The data showed promise for some patient outcomes in the intervention group, particularly with improvements in eating-related distress (p = 0.046 in the Australian data; p = 0.07 in the Hong Kong data), eating-related enjoyment (p = 0.024, Hong Kong data) and quality of life (p = 0.045, Australian data). Energy and protein intake also increased in a clinically meaningful way. Caregiver data on eating-related distress, anxiety, depression and caregiving burden, however, showed little or no change. CONCLUSIONS: Despite challenges with participant recruitment, the intervention demonstrates good potential to have positive effects on patients' nutritional status and eating-related distress. The results of this trial warrant a larger and fully-powered trial to ascertain the effectiveness of this intervention. TRIAL REGISTRATION: The trial was registered with the Australian & New Zealand Clinical Trials Registry, registration number ACTRN12618001352291 .

Nutrition Information in Oncology - Extending the Electronic Patient-Record Data Set.

Electronic health records (EHRs) present extensive patient information and may be used as a tool to improve health care. However, the oncology context presents a complex content that increases the difficulties of EHR application. This study aimed at developing openEHR-archetypes representing clinical concepts in cancer nutrition-care, as well as to develop an openEHR-template including the aforementioned archetypes. The study involved the following stages: 1) a thorough literature review, followed by an expert's (nutrition guideline authors) survey, aiming to identify the main statements of published clinical guidelines on nutrition in cancer patients that were not included on the Clinical Knowledge Manager (CKM) repository; 2) modelling of the archetypes using the Ocean Archetype Software and submission to the CKM repository; 3) creating an example template with Template Designer; and 4) automatic conversion of the openEHR-template into a readily usable EHR using VCIntegrator. The clinical concepts (among 17 clinical concepts not yet available in the CKM repository) chosen for further development were: body composition, diet plan, dietary nutrients, dietary supplements, dietary intake assessment, and Malnutrition Screening Tool (MST). So far, four archetypes were accepted for review in the CKM repository and a template was created and converted into an EHR. This study designed new openEHR-archetypes for nutrition management in cancer patients. These archetypes can be included in EHR. Future studies are needed to assess their applicability in other areas and their practical impact on data quality, system interoperability and, ultimately, on clinical practice and research.

Awareness, perceptions and practices regarding cancer-related malnutrition and sarcopenia: a survey of cancer clinicians.

PURPOSE: Cancer-related malnutrition and sarcopenia have severe negative consequences including reduced survival and reduced ability to complete treatment. This study aimed to determine the awareness, perceptions and practices of Australian oncology clinicians regarding malnutrition and sarcopenia in people with cancer. METHODS: A national cross-sectional survey of Australian cancer clinicians was undertaken between November 2018 and January 2019. The 30-item online purpose-designed survey was circulated through professional organizations and health services. RESULTS: The 111 participants represented dietetic (38%), nursing (34%), medical (14%) and other allied health (14%) clinicians. Overall, 86% and 88% clinicians were aware of accepted definitions of malnutrition and sarcopenia, respectively. Perception of responsibility for identification of these conditions varied across participants, although 93% agreed this was a component of their role. However, 21% and 43% of clinicians had limited or no confidence in their ability to identify malnutrition and sarcopenia, respectively. Common barriers to the identification and management of malnutrition were access to the tools or skills required and a lack of services to manage malnourished patients. Common barriers to identification of sarcopenia were lack of confidence and lack of services to manage sarcopenic patients. Enablers for identification and management of malnutrition and sarcopenia were variable; however, training and protocols for management ranked highly. CONCLUSION: While awareness of the importance of cancer-related malnutrition and sarcopenia are high, participants identified substantial barriers to delivering optimal nutrition care. Guidance at a national level is recommended to strengthen the approach to management of cancer-related malnutrition and sarcopenia.

Similar health economic outcomes in low-risk and high-risk malnourished inpatients as screened by the Malnutrition Screening Tool after delivery of oral nutritional supplements.

OBJECTIVE: The aim of this study was to determine whether modified low- and high-risk Malnutrition Screening Tool (MST) scores (2 versus >2, respectively) were independently predictive of health economic outcomes. METHODS: We analyzed data from a recent nutrition-based quality improvement program (QIP) that prescribed daily oral nutritional supplements for all hospitalized adults at risk for malnutrition. In the original study, an electronic medical records-based MST was administered at the time of admission, and patients were classified as "low risk" or "high risk" for malnutrition based on MST scores (2 versus ≥2). We compared health economic outcomes for patients at low or high risk for malnutrition based on a modified score (MST = 2 versus >2, respectively), looking for between-group differences in length of stay (LOS) and unplanned 30-d readmissions. Analyses were additionally stratified by age (<65 versus ≥65 y of age). RESULTS: Of the 1269 patients enrolled in the QIP, 413 (32.5%) had MST of 2 and 856 (67.5%) had MST >2. Mean LOS was 5.19 d (±4.78) for patients with MST 2 and 4.49 d (±4.69) with MST >2 (non-statistically significant between-group difference; P = 0.277). There were no significant differences in unplanned 30-d readmission rates (14% for low-risk and 17.1% for high-risk patients; P = 0.171). These findings remained statistically insignificant when the low- and high-risk MST score groups were further stratified by age. CONCLUSIONS: Outcomes of hospitalized patients with MST 2 were not significantly different from those with an MST >2. This suggests that patients at both lower and higher risk for malnutrition (based on MST scores of 2 versus ≥3) were similar in terms of LOS and 30-d readmission rates. To avoid overlooking cases of malnutrition risk, the validated cutoff scores for the MST should be consistently implemented. Training that is consistent with the validated MST is recommended rather than attempting to reduce the case burden by "raising the bar" and attempting to classify patients with an MST = 2 as "low risk."

Improving the quality of life of aged care residents through the joy of food: The Lantern Project.

OBJECTIVE: Mealtimes directly impact the quality of life of residents in aged care. The objective of The Lantern Project is to improve the dining experience of aged care residents to reduce malnutrition risk through improving dietary intake, meal. METHODS: A transdisciplinary team of aged care professionals and resident advocates was formed as a collaboration collectively known as The Lantern Project. RESULTS: This paper outlines the journey and timeline of The Lantern Project collaboration since its inception and the interplay between the monthly stakeholder meetings and inter-related research projects demonstrating improved outcomes. CONCLUSION: Transdisciplinary collaboration offers well-grounded benefits and realistic strategies sensitive to the complexity of the aged care setting.

Nutrition interventions in patients with gynecological cancers requiring surgery.

OBJECTIVE: Including developing countries, between 20 and 88% of gynecological oncology patients may present with at least mild malnutrition at diagnosis. Significant morbidity and mortality is attributed to malnutrition. Here we reviewed randomized clinical trials of nutritional interventions used to achieve early return to oral diet, enhance recovery from surgery and reduce adverse events in gynecological cancer patients undergoing surgery. METHODS: Ebscohost (CINAHL+Medline+PsycINFO), Cochrane, Embase, PubMed and Scopus databases were searched for articles published from 2000 onwards. Potentially eligible articles were screened by two reviewers. Length of hospital stay (LOS), postoperative complications, recovery of intestinal function, quality of life (QOL), hematological and immunological parameters were outcome measures of the nutritional interventions. RESULTS: Seven randomized clinical trials were included in the review. Early clear liquid diet, semiliquid diet, regular diet or immune-enhanced enteral diets were all found to be safe as nutritional interventions. In five of the seven trials significantly better outcomes were observed in the intervention group compared to usual care for one of more of the outcomes intestinal recovery time, LOS, postoperative complications and immunological parameters. However, the nutritional interventions varied greatly between the trials, making it difficult to directly compare their findings. Trial quality was low to moderate. Recommended malnutrition screening and assessment tools and guidelines for treatment are reviewed. CONCLUSIONS: From the limited findings it would appear that nutritional interventions of early oral feeding and enteral feeding are safe. Receiving nutritional interventions seems to reduce LOS, intestinal recovery time and postoperative complications for some patients. Increasing use of neoadjuvant treatment may reduce the prevalence of patients presenting malnourished for surgery in the future.

Ginger-Mechanism of action in chemotherapy-induced nausea and vomiting: A review.

Despite advances in antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) still poses a significant burden to patients undergoing chemotherapy. Nausea, in particular, is still highly prevalent in this population. Ginger has been traditionally used as a folk remedy for gastrointestinal complaints and has been suggested as a viable adjuvant treatment for nausea and vomiting in the cancer context. Substantial research has revealed ginger to possess properties that could exert multiple beneficial effects on chemotherapy patients who experience nausea and vomiting. Bioactive compounds within the rhizome of ginger, particularly the gingerol and shogaol class of compounds, interact with several pathways that are directly implicated in CINV in addition to pathways that could play secondary roles by exacerbating symptoms. These properties include 5-HT3, substance P, and acetylcholine receptor antagonism; antiinflammatory properties; and modulation of cellular redox signaling, vasopressin release, gastrointestinal motility, and gastric emptying rate. This review outlines these proposed mechanisms by discussing the results of clinical, in vitro, and animal studies both within the chemotherapy context and in other relevant fields. The evidence presented in this review indicates that ginger possesses multiple properties that could be beneficial in reducing CINV.

In silico investigation into the interactions between murine 5-HT3 receptor and the principle active compounds of ginger (Zingiber officinale).

Gingerols and shogaols are the primary non-volatile actives within ginger (Zingiber officinale). These compounds have demonstrated in vitro to exert 5-HT3 receptor antagonism which could benefit chemotherapy-induced nausea and vomiting (CINV). The site and mechanism of action by which these compounds interact with the 5-HT3 receptor is not fully understood although research indicates they may bind to a currently unidentified allosteric binding site. Using in silico techniques, such as molecular docking and GRID analysis, we have characterized the recently available murine 5-HT3 receptor by identifying sites of strong interaction with particular functional groups at both the orthogonal (serotonin) site and a proposed allosteric binding site situated at the interface between the transmembrane region and the extracellular domain. These were assessed concurrently with the top-scoring poses of the docked ligands and included key active gingerols, shogaols and dehydroshogaols as well as competitive antagonists (e.g. setron class of pharmacologically active drugs), serotonin and its structural analogues, curcumin and capsaicin, non-competitive antagonists and decoys. Unexpectedly, we found that the ginger compounds and their structural analogs generally outscored other ligands at both sites. Our results correlated well with previous site-directed mutagenesis studies in identifying key binding site residues. We have identified new residues important for binding the ginger compounds. Overall, the results suggest that the ginger compounds and their structural analogues possess a high binding affinity to both sites. Notwithstanding the limitations of such theoretical analyses, these results suggest that the ginger compounds could act both competitively or non-competitively as has been shown for palonosetron and other modulators of CYS loop receptors.

Chemotherapy-Induced Nausea and Vomiting: A Narrative Review to Inform Dietetics Practice.

Chemotherapy-induced nausea and vomiting (CINV) are common symptoms experienced by patients with cancer that influence nutrition. They exert a detrimental effect on dietary intake, risk of malnutrition, and quality of life. Whereas CINV are primarily managed with medication, nutrition and dietetics practitioners play an important role in the management of CINV-related complications such as reduced dietary intake. This review discusses the burden of nausea and vomiting that patients with cancer can experience, including the effect on quality of life, nutritional status, and treatment outcomes. Implications for dietetics practice include the need to explore the nature of reported symptoms, identify predisposing risk factors, and to consider the use of a variety of interventions that are individualized to a patient's symptoms. There are little clinical data regarding effective dietetic interventions for nausea and vomiting. In summary, this review discusses dietetics-related issues surrounding CINV, including the pathophysiology, risk factors, prevalence, and both pharmacologic and dietetic treatment options.

Recommendations for Manganese Supplementation to Adult Patients Receiving Long-Term Home Parenteral Nutrition: An Analysis of the Supporting Evidence.

INTRODUCTION: Manganese (Mn) toxicity is often observed in adult patients receiving long-term home parenteral nutrition (HPN), and differing recommendations on the safe level of Mn administration to these patients have been made in the literature over the past 10 years. METHODS: This systematic review used the National Health and Medical Research Council (NHMRC) evidence hierarchy to assess the design and strength of individual studies (high I to low IV) and the overall grade of evidence (grade A high to grade D low). RESULTS: Eight studies met the inclusion criteria. Levels of evidence ranged from high (NHMRC II) to mid-level (III-3). A widespread recommendation in the literature for patients receiving long-term HPN is 55 µg (1 µmol) Mn/d. CONCLUSION: The recommendation of 55 µg (1 µmol) Mn/d is of moderate-strength evidence (NHMRC B grade). There is limited evidence to support not supplementing Mn to patients receiving long-term HPN. Further intervention studies providing high-level evidence (II and above) are required to determine the safety of not supplementing Mn to all patients receiving long-term HPN.

Correction: The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review.

[This corrects the article DOI: 10.1371/journal.pone.0141119.].

The Effect of Ginger (Zingiber officinale) on Platelet Aggregation: A Systematic Literature Review.

BACKGROUND: The potential effect of ginger on platelet aggregation is a widely-cited concern both within the published literature and to clinicians; however, there has been no systematic appraisal of the evidence to date. METHODS: Using the PRISMA guidelines, we systematically reviewed the results of clinical and observational trials regarding the effect of ginger on platelet aggregation in adults compared to either placebo or baseline data. Studies included in this review stipulated the independent variable was a ginger preparation or isolated ginger compound, and used measures of platelet aggregation as the primary outcome. RESULTS: Ten studies were included, comprising eight clinical trials and two observational studies. Of the eight clinical trials, four reported that ginger reduced platelet aggregation, while the remaining four reported no effect. The two observational studies also reported mixed findings. DISCUSSION: Many of the studies appraised for this review had moderate risks of bias. Methodology varied considerably between studies, notably the timeframe studied, dose of ginger used, and the characteristics of subjects recruited (e.g. healthy vs. patients with chronic diseases). CONCLUSION: The evidence that ginger affects platelet aggregation and coagulation is equivocal and further study is needed to definitively address this question.

Is ginger beneficial for nausea and vomiting? An update of the literature.

PURPOSE OF REVIEW: Nausea and vomiting can pose a significant burden to patients in a variety of clinical settings. Previous evidence suggests that ginger may be an effective treatment for these symptoms; however, current evidence has been mixed. This article discusses recent clinical trials that have investigated ginger as a treatment for multiple types of nausea and vomiting. In addition, the potential mechanisms of action of ginger will be discussed. RECENT FINDINGS: This article identified nine studies and seven reviews that investigated ginger for morning sickness, postoperative nausea and vomiting, chemotherapy-induced, and antiretroviral-induced nausea and vomiting. All studies reported that ginger provided a significant reduction in nausea and vomiting; however, the clinical relevance of some studies is less certain. Common limitations within the literature include the lack of standardized extracts, poorly controlled or blinded studies, and limited sample size. In addition, recent evidence has provided further support for 5-HT3 receptor antagonism as a mechanism by which ginger may exert its potentially beneficial effect on nausea and vomiting. SUMMARY: The results of studies in this article suggest that ginger is a promising treatment for nausea and vomiting in a variety of clinical settings and possesses a clinically relevant mechanism. However, further studies are required to address the limitations in the current clinical literature before firm recommendations for its use can be made.

Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial.

BACKGROUND: Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. METHODS/DESIGN: In a double-blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. DISCUSSION: Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. TRIAL REGISTRATION: ANZCTR.org.au Identifier: ACTRN12613000120774.