Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling.

BACKGROUND: Nutritional support, including nutritional counseling and oral nutritional supplements (ONS), has been recommended as a first-line strategy in patients with non-small cell lung cancer (NSCLC). Evidence on the efficacy of immunonutrition during immunotherapy in these patients is positive, but still limited some secondary endpoints, such as treatment toxicity and tolerance. We hypothesize that early systematic provision of ONS with a high-protein-high calorie mixture containing immunonutrients (Impact®) in addition to nutritional counseling, compared to nutritional counseling alone, is beneficial to patients with NSCLC receiving immunotherapy with or without chemotherapy. We designed the present study to evaluate the efficacy of early systematic provision of ONS enriched with immunonutrients compared to nutritional counseling alone, in patients with NSCLC undergoing immunotherapy. Study endpoints were: treatment response (primary endpoint: progression-free survival), treatment tolerance and toxicity, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile. METHODS: This is a pragmatic, multicentre, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial (N = 180). DISCUSSION: The improvement of efficacy of nutritional support in oncology still deserves many efforts. Immunonutrition represents a promising approach also in patients with NSCLC, but evidence on its efficacy on clinical outcomes during immunotherapy is still inconclusive. The present pilot study, which guarantees early high-quality nutritional care (assessment and treatment) to all patients in agreement with current guidelines and recommendations, could represent one of the first proofs of efficacy of early oral immunonutrition in patients with cancer undergoing immunotherapy. Further large randomized trials addressing the improvement of supportive care could be hypothesized, accordingly. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov Identifier: NCT05384873.

Neoadjuvant treatment: A window of opportunity for nutritional prehabilitation in patients with pancreatic ductal adenocarcinoma.

Patients affected by pancreatic ductal adenocarcinoma (PDAC) frequently present with advanced disease at the time of diagnosis, limiting an upfront surgical approach. Neoadjuvant treatment (NAT) has become the standard of care to downstage non-metastatic locally advanced PDAC. However, this treatment increases the risk of a nutritional status decline, which in turn, may impact therapeutic tolerance, postoperative outcomes, or even prevent the possibility of surgery. Literature on prehabilitation programs on surgical PDAC patients show a reduction of postoperative complications, length of hospital stay, and readmission rate, while data on prehabilitation in NAT patients are scarce and randomized controlled trials are still missing. Particularly, appropriate nutritional management represents an important therapeutic strategy to promote tissue healing and to enhance patient recovery after surgical trauma. In this regard, NAT may represent a new interesting window of opportunity to implement a nutritional prehabilitation program, aiming to increase the PDAC patient's capacity to complete the planned therapy and potentially improve clinical and survival outcomes. Given these perspectives, this review attempts to provide an in-depth view of the nutritional derangements during NAT and nutritional prehabilitation program as well as their impact on PDAC patient outcomes.

Exercise prehabilitation in lung cancer: Getting stronger to recover faster.

Despite several recent advances, lung cancer surgery is still associated with potentially severe postoperative complications. It has been suggested that preoperative exercise training could render patients with borderline functional parameters eligible for surgery, improve perioperative outcomes and that these benefits might reduce healthcare costs. Nevertheless, given the substantial heterogeneity of the available studies, no specific guidelines for preoperative exercise training have been released so far. This narrative review aims to provide an overview of the potential benefits of exercise training in the preoperative period as a central intervention for lung cancer patients. In detail, the effects of exercise (with different regimens) were evaluated in terms of physical functions, patients' eligibility for curative surgery, postoperative complications and length of stay, with an exploratory focus on healthcare costs and long-term outcomes. Furthermore, a feasible approach for every-day clinical practice is proposed in order to increase the expected benefit deriving from a more extensive and methodical application of prehabilitation exercise, ideally in the context of a comprehensive approach to lung cancer patients, including nutritional and psychological support.

Factors Influencing Physical Activity in Cancer Patients During Oncological Treatments: A Qualitative Study.

INTRODUCTION: Although the literature supports the importance of physical activity in the oncological context, in Italy a large number of patients are not sufficiently active. METHODS: The present study aimed to explore factors influencing an active lifestyle in cancer patients during oncological treatments. Semi-structured focus groups, including 18 patients with different cancer types, were conducted at the Oncology Unit in the University Hospital Trust of Verona (Italy). The interviews were audio-recorded, transcribed verbatim, and analyzed with content analysis. RESULTS: According to the Health Belief Model, transcripts were categorized into the following themes: benefits, barriers, and cues to action. Patients reported a series of physical, physiological, and psychological benefits deriving from an active lifestyle. The main barriers hampering the physical activity participation were represented by treatment-related side effects, advanced disease, and some medical procedures, for example, ileostomy. Several strategies that can trigger patients to exercise were identified. Medical advice, social support from family and friends, features such as enjoyment, setting goals, and owning an animal can motivate patients to perform physical activity. At the same time, an individualized program based on patients' characteristics, an available physical activity specialist to consult, more detailed information regarding physical activity in the oncological setting, and having accessible structures were found important facilitators to implementing active behavior. CONCLUSIONS: Overall, patients have a positive view regarding physical activity, and a variety of obstacles and cues to action were recognized. Considering this information may help to improve adherence to a physical activity program over time, consequently increasing the expected benefits.

Evaluation of nutritional status in non-small-cell lung cancer: screening, assessment and correlation with treatment outcome.

BackgroundNutritional derangements are common hallmarks of non-small-cell lung cancer (NSCLC). Nevertheless, their early detection is overlooked in clinical routine. This study aimed to evaluate nutritional status and its correlation with outcome in NSCLC patients.MethodsData regarding NSCLC patients undergoing nutritional evaluation were prospectively collected (May 2016-October 2018). Nutritional risk was assessed by Nutritional Risk Screening 2002 (NRS-2002). Bilateral psoas major muscles were measured at L3 vertebrae level with routine staging-computed tomography and changes were evaluated using Wilcoxon signed-rank test. Clinico-pathological and nutritional data were correlated to progression-free/overall survival (PFS/OS) and response rate (ORR) using a Cox and logistic regression model. Kaplan-Meier curves were compared with log-rank test.ResultsThirty-eight patients were included. The majority (65.8%) of them were at nutritional risk (NRS-2002 ≥3). At multivariate analysis for patients with advanced disease, age (HR 2.44, p=0.05), performance status (HR 2.48, p=0.043) and NRS-2002 (HR 1.74, p=0.001) were significant independent predictors for PFS and weight loss (HR 1.07, p=0.008) for OS. Patients with baseline NRS-2002 <3 had significantly longer 1-year PFS (85.7% vs 19.4%, p=0.02) and higher ORR (66.7% vs 21.4%) than those with NRS-2002 ≥3. An explorative evaluation demonstrated that NRS-2002 score significantly decreased after nutritional intervention (p=0.001) for 3 months.ConclusionBaseline nutritional risk represents a prognostic factor in NSCLC. Nutritional counselling should be applied as a fundamental tool to improve nutritional risk in a short period, ameliorating patients' outcome.