Effectiveness of Preoperative Immunonutrition in Improving Surgical Outcomes after Radical Cystectomy for Bladder Cancer: Study Protocol for a Multicentre, Open-Label, Randomised Trial (INu-RC).

Radical cystectomy (RC) with pelvic lymph node dissection is the standard treatment for patients with limited-stage muscle-invasive bladder cancer. RC is associated with a complication rate of approximately 50-88%. Immunonutrition (IMN) refers to the administration of substrates, such as omega-3 fatty acids, arginine, glutamine, and nucleotides, that modulate the immune response. IMN has been associated with improved outcomes following surgery for esophagogastric, colorectal and pancreatic cancer. In this paper, we describe a study protocol for a multicentre, randomised, open-label clinical trial to evaluate the effect of IMN in patients undergoing RC for bladder cancer. A 7-day preoperative course of IMN is compared with a standard high-calorie high-protein oral nutritional supplement. The primary outcome of this study is the rate of complications (infectious, wound-related, gastrointestinal, and urinary complications) in the first 30 days after RC. Secondary outcomes include time to recovery of bowel function and postoperative mobilisation, changes in muscle strength and body weight, biochemical modifications, need for blood transfusion, length of stay, readmission rate, and mortality. The results of this study may provide new insights into the impact of IMN on postoperative outcomes after RC and may help improve IMN prescribing based on patient nutritional status parameters.

Stakeholders' Perspective on the Key Features of Printed Educational Resources to Improve the Quality of Clinical Communication.

Social and healthcare professionals often feel ill equipped to effectively engage in difficult conversations with patients, and poor proficiency negatively affects the quality of patient care. Printed educational resources (PERs) that provide guidance on sustaining complex clinical communication may be a source of support if thoughtfully designed. This study aimed to describe the key features of PERs in order to improve the quality of clinical communication according to the perspective of meaningful stakeholders. This was a descriptive secondary analysis of data collected by three remote focus group discussions that involved 15 stakeholders in the context of developing an educational booklet to support professionals in complex communication scenarios. Focus groups were audio-recorded and transcribed verbatim, and an inductive thematic analysis was performed. Three key features of PERs that aim toward quality improvement in clinical communication were identified: (1) having the potential to provide benefits in clinical practice; (2) facilitating, encouraging, and enticing reading; and (3) meeting the need of professionals to improve or update their knowledge. These findings suggest that PERs relevant to professionals' clinical priorities and learning needs may make their efforts to apply learning in practice more likely and consequently result in improved healthcare quality.

High-protein home parenteral nutrition in malnourished oncology patients: a systematic literature review.

INTRODUCTION: Up to 83% of oncology patients are affected by cancer-related malnutrition, depending on tumour location and patient age. Parenteral nutrition can be used to manage malnutrition, but there is no clear consensus as to the optimal protein dosage. The objective of this systematic literature review (SLR) was to identify studies on malnourished oncology patients receiving home parenteral nutrition (HPN) where protein or amino acid delivery was reported in g/kg bodyweight/day, and to compare outcomes between patients receiving low (< 1 g/kg bodyweight/day), standard (1-1.5 g/kg/day), and high-protein doses (> 1.5 g/kg/day). METHODS: Literature searches were performed on 5th October 2021 in Embase, MEDLINE, and five Cochrane Library and Centre for Reviews and Dissemination databases. Searches were complemented by hand-searching of conference proceedings, a clinical trial registry, and bibliographic reference lists of included studies and relevant SLRs/meta-analyses. RESULTS: Nineteen publications were included; sixteen investigated standard protein, two reported low protein, and one included both, but none assessed high-protein doses. Only one randomised controlled trial (RCT) was identified; all other studies were observational studies. The only study to compare two protein doses reported significantly greater weight gain in patients receiving 1.15 g/kg/day than those receiving 0.77 g/kg/day. CONCLUSION: At present, there is insufficient evidence to determine the optimal protein dosage for malnourished oncology patients receiving HPN. Data from non-HPN studies and critically ill patients indicate that high-protein interventions are associated with increased overall survival and quality of life; further studies are needed to establish whether the same applies in malnourished oncology patients.

Supplemental parenteral nutrition in cancer care: why, who, when.

Malnutrition is an often-overlooked challenge for patients with cancer. It is associated with muscle mass reduction, poor compliance and response to cancer treatments, decreased quality of life, and reduced survival time. The nutritional assessment and intervention should be a vital part of any comprehensive cancer treatment plan. However, data on artificial nutrition supplied based on caloric needs during cancer care are scarce. In this review, we discuss the recommendations of the European and American societies for clinical nutrition on the use of nutritional interventions in malnourished patients with cancer in the context of current clinical practice. In particular, when enteral nutrition (oral or tube feeding) is not feasible or fails to meet the complete nutritional needs, supplemental parenteral nutrition (SPN) can bridge the gap. We report the available evidence on SPN in cancer patients and identify the perceived barriers to the wider application of this intervention. Finally, we suggest a 'permissive' role of SPN in cancer care but highlight the need for rigorous clinical studies to further evaluate the use of SPN in different populations of cancer patients.

Nutritional Support in Cancer patients: update of the Italian Intersociety Working Group practical recommendations.

Malnutrition is a frequent problem in cancer patients, which leads to prolonged and repeated hospitalizations, increased treatment-related toxicity, reduced response to cancer treatment, impaired quality of life, a worse overall prognosis and the avoidable waste of health care resources. Despite being perceived as a limiting factor in oncologic treatments by both oncologists and patients, there is still a considerable gap between need and actual delivery of nutrition care, and attitudes still vary considerably among health care professionals. In the last 5 years, the Italian Intersociety Working Group for Nutritional Support in Cancer Patients (WG), has repeatedly revisited this issue and has concluded that some improvement in nutritional care in Italy has occurred, at least with regard to awareness and institutional activities. In the same period, new international guidelines for the management of malnutrition and cachexia have been released. Despite these valuable initiatives, effective structural strategies and concrete actions aimed at facing the challenging issues of nutritional care in oncology are still needed, requiring the active participation of scientific societies and health authorities. As a continuation of the WG's work, we have reviewed available data present in the literature from January 2016 to September 2021, together with the most recent guidelines issued by scientific societies and health authorities, thus providing an update of the 2016 WG practical recommendations, with suggestions for new areas/issues for possible improvement and implementation.

Caring for Patients in Need of Palliative Care: Is This a Mission for Acute Care Hospitals? Key Questions for Healthcare Professionals.

The prevalence of patients affected by end-stage diseases or advanced cancer is increasing due to an aging population and progression in medicine and public healthcare. The burden of symptoms these people suffer in the last months of life often forces them to seek aid in an emergency department. In developed countries, acute care hospital-based services are often better designed to treat acute clinical conditions than to manage the needs of patients with serious chronic diseases. Thus, the palliative care (PC) population poses very real clinical challenges to healthcare professionals who care for them in hospital settings. The authors have formulated four key questions (who, why, when, and how) to address in order to identify a model for providing the best care for these PC patients. The questions are related to: (1) defining people living with serious chronic diseases; (2) managing the challenge of unplanned hospital admission of these people; (3) identifying PC patients among people with serious chronic diseases; and (4) determining the appropriate work of caring for this inpatient PC population. Clinicians need the knowledge, tools, and services to care for these PC patients, and acute care hospitals should plan the work of caring for these inpatients.

Home parenteral nutrition versus artificial hydration in malnourished patients with cancer in palliative care: a prospective, cohort survival study.

OBJECTIVE: The evidence base for home parenteral nutrition (HPN) in patients with advanced cancer is lacking. To compare the survival of malnourished patients with cancer undergoing palliative care who received HPN with a homogeneous group of patients, equally eligible for HPN, who did not receive HPN. DESIGN: Prospective, cohort study; tertiary university hospital, home care, hospice. METHODS: Patients were assessed for HPN eligibility according to the guidelines. In the eligible population, who received both HPN and chemotherapy was excluded, while who received only HPN was included in the HPN+ group and who received neither HPN nor chemotherapy but artificial hydration (AH) was included in the HPN- group. RESULTS: 301 patients were assessed for HPN eligibility and 86 patients (28.6%) were excluded for having severe organ dysfunction or Karnofsky performance status <50. In outcome analysis, 90 patients (29.9%) were excluded for receiving both HPN and chemotherapy, while 125 (41.5%) were included, 89 in HPN+ group (29.5%) and 36 in HPN- group (12%). The survival of the two groups showed a significant difference favouring patients receiving HPN (median overall survival: 4.3 vs 1.5 months, p<0.001). The multivariate analysis of the risk factors for mortality showed that not receiving HPN accounted for the strongest one (HR 25.72, 95% CI 13·65 to 48.44). CONCLUSIONS: Comparative survival associated with the use of HPN versus AH showed significantly longer survival in malnourished patients with advanced cancer receiving HPN. These data support the guideline recommendation that HPN should be considered when malnutrition represents the overriding threat for the survival of these patients.

The Impact of Health and Social Care Professionals' Education on the Quality of Serious Illness Conversations in Nursing Homes: Study Protocol of a Quality Improvement Project.

Health and social care professionals (HCPs) who work in nursing homes (NHs) are increasingly required to sustain serious illness conversations about care goals and preferences. Although these conversations may also be challenging for experienced HCPs and the literature recognizes high-quality communication as key to providing patient-centered care, so far, no specific educational program has been developed for the NH setting to improve HCPs' communication skills. Our study aims to test the feasibility and potential effectiveness of an innovative, blended communication skills training program (Teach-to-Communicate) targeting the HCPs who work in NHs. This program includes classroom-based theory, experiential learning, and e-learning, and relies on interdisciplinary contexts and several didactic methods. The study consists of two phases: phase I is the development of written resources that employ focus group discussion involving field experts and external feedback from key stakeholders. Phase II consists of a multicenter, pilot, pre-post study with nested qualitative study. The Teach-to-Communicate training program is expected to enhance the quality of communication in NH and HCPs' confidence in sustaining serious illness conversations, reduce family carers' psycho-emotional burden and improve their satisfaction with the care received, and increase advance care planning documentation. Our protocol will provide insight for future researchers, healthcare providers, and policymakers and pave the way for blended educational approaches in the field of communication skills training.

Immune Checkpoint Inhibitors and Opioids in Patients with Solid Tumours: Is Their Association Safe? A Systematic Literature Review.

BACKGROUND: Immune checkpoint inhibitors (ICIs) represent one of the most effective treatments for patients with cancer. As their activity relies on host immune system reactivity, the role of concomitant medications such as corticosteroids and antibiotics has been extensively evaluated. Preclinical data suggest that opioids may influence the immune system. METHODS: a systematic literature revision was performed using specific keywords on the major search engines. Two authors analysed all the studies and provided a selection of the following inclusion and exclusion criteria, respectively: 1. data collection of patients older than 18 years old affected by solid tumours; 2. description of ICIs efficacy in terms of PFS, OS, TTF, and ORR; 3. concomitant ICIs-opioids treatment and 1. language different from English; 2. not pertinent analyses. RESULTS: 523 studies were analysed, and 13 were selected and included in our series. A possible negative interaction between oral opioids and ICIs efficacy was observed. Most evidence was retrospective, and studies were heterogeneous. CONCLUSIONS: Even if oral opioids seem to impact negatively on ICIs efficacy in cancer patients, to date there is not sufficient evidence to avoid their prescription in this population.

The Role of Nutritional Support for Cancer Patients in Palliative Care.

The role of nutritional support for cancer patients in palliative care is still a controversial topic, in part because there is no consensus on the definition of a palliative care patient because of ambiguity in the common medical use of the adjective palliative. Nonetheless, guidelines recommend assessing nutritional deficiencies in all such patients because, regardless of whether they are still on anticancer treatments or not, malnutrition leads to low performance status, impaired quality of life (QoL), unplanned hospitalizations, and reduced survival. Because nutritional interventions tailored to individual needs may be beneficial, guidelines recommend that if oral food intake remains inadequate despite counseling and oral nutritional supplements, home enteral nutrition or, if this is not sufficient or feasible, home parenteral nutrition (supplemental or total) should be considered in suitable patients. The purpose of this narrative review is to identify in these cancer patients the area of overlapping between the two therapeutic approaches consisting of nutritional support and palliative care in light of the variables that determine its identification (guidelines, evidence, ethics, and law). However, nutritional support for cancer patients in palliative care may be more likely to contribute to improving their QoL when part of a comprehensive early palliative care approach.

Comparative Complication Rates of 854 Central Venous Access Devices for Home Parenteral Nutrition in Cancer Patients: A Prospective Study of Over 169,000 Catheter-Days.

BACKGROUND: Whether peripherally inserted central catheters (PICCs) are appropriate as safe and durable venous access devices (VADs) is still controversial. The aim of this 7-year, prospective cohort study was to compare the incidence rate differences of catheter-related complications (CRCs) among 4 types of central VADs in cancer patients receiving home parenteral nutrition (HPN). METHODS: We enrolled all adult cancer outpatients who were candidates for HPN and who had a central VAD inserted during the study period, focusing on the incidence rate of CRCs. RESULTS: We evaluated 854 central VADs (401 PICCs, 137 nontunneled centrally inserted central catheters [CICCs], 118 tunneled-cuffed CICCs, and 198 ports) in 761 patients, for a total of 169,116 catheter-days. Overall, the rate of total CRCs was 1.08/1000 catheter-days. The incidence of catheter-related bloodstream infections was low (0.29/1000), particularly for PICCs (0.08/1000; P < .001 vs tunneled-cuffed CICCs) and for ports (0.21/1000; P < .019 vs tunneled-cuffed CICCs). The rates of mechanical complications (0.58/1000) and of catheter-related symptomatic thrombosis (0.09/1000) were low and similar for PICCs, tunneled-cuffed CICCs, and ports. In terms of duration and removal rate due to complications, PICCs were like tunneled-cuffed CICCs and ports. Altogether, PICCs had fewer total complications than tunneled-cuffed CICCs (P < .001), there was no difference in total complications between PICCs and ports. CONCLUSION: PICCs had significantly better outcomes than tunneled-cuffed CICCs and were safe and durable as ports. Our extensive, long-term study suggests that PICCs can be successfully used as safe and long-lasting VADs for HPN in cancer patients.

Impact of Artificial Nutrition on Postoperative Complications.

Malnutrition is common in surgical cancer patients and it is widely accepted that it can adversely affect their postoperative outcome. Assessing the nutritional status of every patient, in particular care of elderly and cancer patients, is a crucial feature of the therapeutic pathway in order to optimize every strategy. Evidence exists that the advantages of perioperative nutrition are more significant in malnourished patients submitted to major surgery. For patients recognized as malnourished, preoperative nutrition therapies are indicated; the choice between parenteral and enteral nutrition is still controversial in perioperative malnourished surgical cancer patients, although enteral nutrition seems to have the best risk-benefit ratio. Early oral nutrition after surgery is advisable, when feasible, and should be administered in all the patients undergoing elective major surgery, if compliant. In patients with high risk for postoperative infections, perioperative immunonutrition has been proved in some ways to be effective, even if operations including those for cancer have to be delayed.

Monitoring Response to Home Parenteral Nutrition in Adult Cancer Patients.

Current guidelines recommend home parenteral nutrition (HPN) for cancer patients with chronic deficiencies of dietary intake or absorption when enteral nutrition is not adequate or feasible in suitable patients. HPN has been shown to slow down progressive weight loss and improve nutritional status, but limited information is available on the monitoring practice of cancer patients on HPN. Clinical management of these patients based only on nutritional status is incomplete. Moreover, some commonly used clinical parameters to monitor patients (weight loss, body weight, body mass index, and oral food intake) do not accurately reflect patient's body composition, while bioelectrical impedance analysis (BIA) is a validated tool to properly assess nutritional status on a regular basis. Therefore, patient's monitoring should rely on other affordable indicators such as Karnofsky Performance Status (KPS) and modified Glasgow Prognostic Score (mGPS) to also assess patient's functional status and prognosis. Finally, catheter-related complications and quality of life represent crucial issues to be monitored over time. The purpose of this narrative review is to describe the role and relevance of monitoring cancer patients on HPN, regardless of whether they are receiving anticancer treatments. These practical tips may be clinically useful to better guide healthcare providers in the nutritional care of these patients.

Clinical characteristics and predictive factors of survival of 761 cancer patients on home parenteral nutrition: A prospective, cohort study.

BACKGROUND: Robust data reporting the survival of cancer patients on home parenteral nutrition (HPN) are lacking. The aim of this prospective, cohort study was to investigate clinical characteristics, predictive factors, and overall survival (OS) of adult-malnourished cancer patients eligible for HPN according to the European guideline recommendations. METHODS: During the study period, 1658 cancer patients were consecutively evaluated in a tertiary university hospital. Of these, 761 who received HPN were grouped into four cohorts according to the provision of supplemental PN (SPN) or total (TPN) and whether they received chemotherapy (CT+ or CT- ): SPN/CT+ (n = 376), TPN/CT+ (n = 99), SPN/CT- (n = 191), and TPN/CT- (n = 95). Patient demographics, nutritional status, cancer-related characteristics, and prognostic scores assessed at HPN start. The primary outcome was OS. RESULTS: Median OS was 8.9, 4.3, 5.7, and 2.2 months for the SPN/CT+ , TPN/CT+ , SPN/CT- , and TPN/CT- cohorts, respectively. In multivariable analysis, predictors showing significant association with decreased survival were patient cohorts, modified Glasgow Prognostic Score (1 and 2 scores), weight loss (>15%) in the 3 months before HPN start, and TNM IV stage while protective factors of survival were Karnofsky Performance Status (>50), albumin level (>3.5 g/dL), oral protein intake, BMI (>20.5), and weight at HPN start. CONCLUSION: For the first time, in four different cohorts of cancer patients on HPN, clinical characteristics and survival were compared. This large study showed that survival is significantly correlated with patient characteristics at HPN start and that the presence of favorable factors may determine even a fourfold increase in survival. These data are expected to assist physicians in the appropriate prescription of HPN.

The Advantages of Clinical Nutrition Use in Oncologic Patients in Italy: Real World Insights.

This retrospective observational study aimed to provide insights on the use of clinical nutrition (CN) (enteral and parenteral feeding) and outcomes in an Italian real-world setting. The data source comes from administrative databases of 10 Italian Local Health Units. Patients diagnosed with malignant neoplasms from 1 January 2010 to 31 December 2015 were included. Metastasis presence was ascertained by discharge diagnosis in the hospitalization database. CN was identified by specific codes from pharmaceutical and hospitalization databases. Two cohorts were created-one for metastatic patients (N = 53,042), and one for non-metastatic patients (N = 4379) receiving CN. Two survival analyses were set for the cohort of metastatic patients-one included patients receiving CN and the second included malnourished patients. Our findings show that (1) administration of CN is associated with positive survival outcomes in metastatic patients with gastrointestinal, respiratory, and genitourinary cancer; (2) CN in malnourished metastatic patients with gastrointestinal and genitourinary cancer was associated with significant improvement in survival; (3) early administration of CN was associated with improvement in survival in non-metastatic patients with gastrointestinal cancer (HR 95%CI: 0.5 (0.4-0.6), p-value < 0.05). This study highlights the need to improve the assessment of nutritional status in oncologic patients and suggests a potential survival benefit of CN treatment in metastatic disease.

Nutritional Issues in Head and Neck Cancer Patients.

The purpose of this paper is to update the oncologist on the correct approach to the nutritional care of the head and neck cancer patient. Recent scientific contributions on this issue, with a special emphasis on international guidelines and randomised clinical trials (RCTs), are reviewed. The following points are noteworthy: 1. Despite the advances in early diagnosis and modern treatment of head and neck cancer, this tumour still ranks first regarding frequency and severity of weight loss, both at the clinical presentation and during the therapy. 2. This is due to the combination of poor alimentation because of the tumour mass localization, as well as of the presence of an inflammatory response which furtherly drives catabolism. 3. Several studies have shown a very limited role for a dietary counselling unless it includes oral nutritional supplements which are protein or omega-3 fatty acid enriched. 4. A parental nutritional supplementation could represent an acceptable short-term alternative. 5. Long-term nutritional support relies on the use of percutaneous endoscopic gastrostomy (PEG), whereas the role of a prophylactic or "a la demande" PEG is still unsettled and requires further investigations. In conclusion, the nutritional approach using specific formulas and the appropriate route of administration should be part of the therapeutic armamentarium of the modern oncologist.