Feasibility of a novel exercise program for patients with breast cancer offering different modalities and based on patient preference.

PURPOSE: Exercise improves quality of life and reduces the side effects of cancer therapies. Nevertheless, attendance to exercise programs remains a challenge for patients. This study explored the feasibility of an exercise program in which women with breast cancer may be allowed to choose among three exercise delivery modalities. METHODS: Forty-seven patients with breast cancer (stage I-IV) participated in a 12-week combined aerobic and resistance training program. The exercise modality was chosen by patients according to their preferences and needs among three options: the personal training program, the home-based program, or the group-based program. Exercise prescription was similar between the three modalities. Whereas the primary endpoint was feasibility, assessed through recruitment rate, attendance, adherence, dropout rate, tolerability, and safety, secondary endpoints included health-related skills and quality of life. RESULTS: Out of 47 recruited patients, 24 chose the home-based program, 19 the personal training program, and four the group-based program. Six dropouts (13%) were registered, and no severe adverse events were recorded. The median program attendance was 98% for personal training programs, 96% for home-based programs, and 100% for group-based programs, whereas compliance resulted in more than 90% in each modality. At postintervention, a significant increase in cardiorespiratory fitness, lower body flexibility, and body weight was observed. Different quality-of-life domains were improved following the intervention, including physical and social functioning, fatigue, and appetite loss. No significant changes in other parameters were detected. CONCLUSIONS: An exercise prescription based on a patient-preferred delivery modality showed high feasibility in women with breast cancer.

Cross-sectional survey evaluating the psychological impact of the COVID-19 vaccination campaign in patients with cancer: The VACCINATE study.

The COVID-19 pandemic has profoundly impacted on cancer patients' psychological well-being and clinical status. We assessed the levels of anxiety, depression, and distress and the attitude towards COVID-19 vaccination in cancer patients, accepting vaccination at the Verona University Hospital and Camposampiero Hospital in the Veneto region. Self-reported questionnaires were administered to patients undergoing COVID-19 vaccination between March and May 2021 (first and second dose). Twenty-seven items were investigated: i) demographics/clinical characteristics; ii) anxiety, depression, and distress (Hospital Anxiety and Depression Scale-HADS-and Distress Thermometer-DT); iii) four specific items regarding awareness about infection risks, interference with anticancer treatments, and vaccine side effects. Sixty-two and 57% of the patients who accepted to be vaccinated responded to the survey in the two participating Hospitals, respectively. Mean age was 63 years (SD: 12 years; range 19-94 years), women were slightly more prevalent (57.6%), most participants were married (70%), and either worker or retired (60%). Borderline and clinical levels of anxiety were recorded in 14% and 10% of respondents; borderline and clinical levels of depression in 14% and 8%; and moderate and severe distress levels in 33% and 9%. Overall, there was high confidence that vaccination would reduce the risk of contracting COVID-19 (70%), which would make patients feel less worried about contracting the infection (60%). Fear that vaccine-related side effects would interfere with anticancer treatment and/or global health status was low (10% and 9% for items 3 and 4, respectively) and significantly associated with baseline levels of anxiety, depression, and distress at multivariate analysis. Results did not differ between the Verona and Camposampiero cohorts. During the COVID-19 vaccination campaign, adult cancer patients demonstrated high levels of confidence towards vaccination; baseline levels of anxiety, depression, and distress were the only significant predictors of reduced confidence.

A Feasibility Study Investigating an Exercise Program in Metastatic Cancer Based on the Patient-Preferred Delivery Mode.

BACKGROUND: Feasibility of exercise in patients with metastatic cancer is still a challenge. This study aimed to determine the feasibility and preliminary efficacy of an exercise intervention based on a patient-preferred delivery mode in patients affected by metastatic cancer. MATERIALS AND METHODS: Forty-four patients with a confirmed diagnosis of metastatic cancer were recruited in a 3-month exercise program. Whereas the exercise program consisted of aerobic and resistance activities performed twice a week, the participants may choose the mode of delivery: home based, personal training, or group based. The primary endpoint was the feasibility, defined by recruitment rate, attendance, adherence, dropout rate, tolerability (comparing the session RPE with the target RPE), and safety (using the Common Terminology Criteria for Adverse Events, version 5.0). Secondary endpoints included cardiorespiratory fitness (six minutes walking test), muscle strength (handgrip strength test and isometric leg press test), flexibility (the back scratch and chair sit and reach tests), anthropometric parameters (body mass index and waist-hip ratio), quality of life (EORTC QLQ C-30 questionnaire), and amount of physical exercise (Godin's Shepard Leisure Time Exercise Questionnaire). Descriptive statistics, Student t test, and Wilcoxon signed rank test were used to analyze data. RESULTS: The study recruitment rate was 81%. Out of 44 recruited patients, 28 chose the personal training program, 16 chose the home-based program, and none chose the group-based program. Nine dropouts occurred (20%), 6 in the personal training program, and 3 in the home-based intervention. The median attendance rate was 92%, adherence was 88%, tolerability was 100%, and 9 nonsevere adverse events were registered during the exercise sessions. An increase in cardiorespiratory fitness (P < .001) and flexibility (P = .011 for chair sit and reach; P = .040 for back scratch) was observed at the end of the intervention, while no changes in anthropometric values and muscle strength were detected. Different quality-of-life domains were improved following the intervention, including physical (P = .002), emotional (P < .001), and role functioning (P = .018), fatigue (P = .030), and appetite loss (P = .005). CONCLUSION: A 3-month exercise program based on a patient-preferred delivery mode is feasible in patients with metastatic cancer and may improve physical function and quality of life. TRIAL REGISTRATION: NCT04226508.

Adjuvant Targeted Therapy in Solid Cancers: Pioneers and New Glories.

Targeted therapy (TT) has revolutionized cancer treatment, successfully applied in various settings. Adjuvant TT in resected early-stage gastrointestinal stromal tumors (GIST), melanoma, non-small cell lung cancer (NSCLC), and breast cancer has led to practice-changing achievements. In particular, standard treatments include BRAF inhibitors for melanoma, osimertinib for NSCLC, hormone therapy or HER2 TT for breast cancer, and imatinib for GIST. Despite the undeniable benefit derived from adjuvant TT, the optimal duration of TT and the appropriate managing of the relapse remain open questions. Furthermore, neoadjuvant TT is emerging as valuable, particularly in breast cancer, and ongoing studies evaluate TT in the perioperative setting for early-stage NSCLC. In this review, we aim to collect and describe the large amount of data available in the literature about adjuvant TT across different histologies, focusing on epidemiology, major advances, and future directions.

Corrigendum: Body composition parameters, immunonutritional indexes, and surgical outcome of pancreatic cancer patients resected after neoadjuvant therapy: a retrospective, multicenter analysis.

[This corrects the article DOI: 10.3389/fnut.2023.1065294.].

Body composition parameters, immunonutritional indexes, and surgical outcome of pancreatic cancer patients resected after neoadjuvant therapy: A retrospective, multicenter analysis.

Background and aims: Body composition parameters and immunonutritional indexes provide useful information on the nutritional and inflammatory status of patients. We sought to investigate whether they predict the postoperative outcome in patients with pancreatic cancer (PC) who received neoadjuvant therapy (NAT) and then pancreaticoduodenectomy. Methods: Data from locally advanced PC patients who underwent NAT followed by pancreaticoduodenectomy between January 2012 and December 2019 in four high-volume institutions were collected retrospectively. Only patients with two available CT scans (before and after NAT) and immunonutritional indexes (before surgery) available were included. Body composition was assessed and immunonutritional indexes collected were: VAT, SAT, SMI, SMA, PLR, NLR, LMR, and PNI. The postoperative outcomes evaluated were overall morbidity (any complication occurring), major complications (Clavien-Dindo ≥ 3), and length of stay. Results: One hundred twenty-one patients met the inclusion criteria and constituted the study population. The median age at the diagnosis was 64 years (IQR16), and the median BMI was 24 kg/m2 (IQR 4.1). The median time between the two CT-scan examined was 188 days (IQR 48). Skeletal muscle index (SMI) decreased after NAT, with a median delta of -7.8 cm2/m2 (p < 0.05). Major complications occurred more frequently in patients with a lower pre-NAT SMI (p = 0.035) and in those who gained in subcutaneous adipose tissue (SAT) compartment during NAT (p = 0.043). Patients with a gain in SMI experienced fewer major postoperative complications (p = 0.002). The presence of Low muscle mass after NAT was associated with a longer hospital stay [Beta 5.1, 95%CI (1.5, 8.7), p = 0.006]. An increase in SMI from 35 to 40 cm2/m2 was a protective factor with respect to overall postoperative complications [OR 0.43, 95% (CI 0.21, 0.86), p < 0.001]. None of the immunonutritional indexes investigated predicted the postoperative outcome. Conclusion: Body composition changes during NAT are associated with surgical outcome in PC patients who receive pancreaticoduodenectomy after NAT. An increase in SMI during NAT should be favored to ameliorate the postoperative outcome. Immunonutritional indexes did not show to be capable of predicting the surgical outcome.

Predictive and prognostic effect of computed tomography-derived body composition analysis during neoadjuvant chemotherapy for operable and locally advanced breast cancer.

OBJECTIVES: Excess adiposity is associated with several factors involved in carcinogenesis and breast cancer progression. Evidence supporting the role of body composition in breast cancer treatment is promising, but still scanty and mainly focused on adjuvant treatment. The aim of this study was to evaluate the changes in body composition during neoadjuvant chemotherapy and its association with pathologic complete response and survival outcome in patients treated for operable/locally advanced breast cancer. METHODS: A retrospective review of patients with breast cancer treated with neoadjuvant chemotherapy was performed in the Oncology Section of the Department of Medicine, University of Verona between 2014 and 2019. Body composition was evaluated from clinically acquired computed tomography scans at diagnosis and after neoadjuvant chemotherapy. Descriptive statistic was adopted. The associations of body composition measures with pathologic complete response and disease-free survival were analyzed. Kaplan-Meier curves were compared with log-rank analysis. RESULTS: Data from 93 patients were collected. After neoadjuvant chemotherapy, the adipose compound changed significantly across all body mass index categories. Body composition parameters had no significant effect on pathologic complete response. Survival analysis showed that a high gain of visceral adipose tissue during neoadjuvant chemotherapy was associated with shorter disease-free survival (hazard ratio, 10.2; P = 0.026). In particular, disease-free survival was significantly worse in patients who gained ≥10% of visceral adipose tissue compared with patients who gained <10% of visceral adipose tissue (5-y disease-free survival 71.4 versus 96.3, P = 0.009, respectively). CONCLUSIONS: Our results indicated that neoadjuvant chemotherapy significantly affects body composition, which seems to have an effect on survival outcome of breast cancer, highlighting the relevance of the body composition assessment when estimating treatment outcomes.

Willingness, preferences, barriers, and facilitators of a multimodal supportive care intervention including exercise, nutritional and psychological approach in patients with cancer: a cross-sectional study.

PURPOSE: Supportive care, including exercise, nutritional and psychological support, is becoming increasingly important in cancer given their impact on 'patients' quality and quantity of life. The purpose of this study was to explore willingness, preferences barriers and facilitators for a multimodal intervention in patients with cancer. METHODS: An anonymous questionnaire was proposed on randomly selected days to the patients visiting the cancer outpatients' facilities at the Oncology Unit of the University Hospital of Verona. The questionnaire investigated willingness, preferences, barriers, and facilitators associated with participation in a multimodal program designed for patients with cancer. Exercise level was estimated using two open questions, nutritional risk was identified using the Nutritional Risk Screening 2002, while distress was evaluated with the Distress Thermometer. RESULTS: Based on 324 participants, 65% were interested in starting a multimodal intervention. Patients declared to prefer to receive instructions from dedicated experts, with a face-to-face approach, and during the anticancer treatment. Treatment-related side effects were the major obstacles for a multimodal program, while the availability of a specialized staff as exercise kinesiologists, dietitians, and psycho-oncologists was found to be an important facilitator for increasing 'patients' participation. CONCLUSION: Patients patients with cancer are interested in participating in a multimodal supportive care program specifically designed for them. Information from this study may help to design a tailored multimodal intervention for patients with cancer.

Development of Educational Print Materials for Physical Activity in Cancer: Evaluation of Readability and Suitability.

Educational health materials may be important tools to increase physical activity in cancer patients. Nevertheless, most of the available resources regarding physical activity for cancer patients were found not suitable, had a low grade of readability, and thus, represent a significant barrier to behavior change. To date, little data about development criteria and evaluation of physical activity resources for cancer before their spread exist. The purposes of this study were (i) to describe the development of a physical activity guidebook designed for cancer patients and (ii) to test its readability and suitability. The guidebook was developed through multi-step passages, including group discussions, a literature review, identification of a motivational theory, and using previous research on exercise preferences, barriers, and facilitators to target the information. Two validated formulae were used to assess the readability, whereas thirty-four judges completed the Suitability of Assessment Materials questionnaire to evaluate the suitability of the guidebook. The guidebook was found readable for patients having at least a primary education, and the judges scored it as "superior" material. Our guidebook, following a rigorous method in the development phase, was considered to be suitable and readable. Further evaluations through clinical trials could investigate its effectiveness for behavior change and its impact on cancer patients.

Exploring the feasibility of a combined exercise program for patients with advanced lung or pancreatic cancer.

Objective: This study aims to assess the safety, feasibility, and potential benefits of a combined aerobic and resistance exercise intervention for patients diagnosed with advanced pancreatic or lung cancer. Methods: A prospective, single-arm study was conducted, enrolling patients with advanced lung or pancreatic cancer. Participants engaged in a 12-week exercise intervention comprising personalized bi-weekly aerobic and resistance training tailored to individual baseline conditions. The primary study outcomes focused on safety (absence of serious adverse events) and feasibility. Secondary outcomes included assessments of functional capacity using the "Six minutes walking test", strength measured through handgrip and leg press tests, anthropometric measures including body mass index and waist-hip ratio, quality of life (QoL), and changes in blood parameters. Results: The study involved twelve patients (mean age 57.66 â€‹± â€‹7.40 years), with seven having pancreatic cancer and five having lung cancer. The recruitment rate was 50%, and assessment adherence was 100%, with an 84% adherence to the exercise program and no dropouts. No exercise-related adverse events were recorded, while three non-severe, non-exercise-related adverse events were observed: treatment-related dermatitis (Grade 2), axillary lymphadenopathy (Grade 2), and migraine (Grade 1). Significant enhancements in functional capacity, emotional well-being, and social functioning within the QoL domains were observed. Anthropometric measures, specifically waist-hip ratio and body mass index, remained stable. Conclusions: The findings suggest that a tailored 12-week exercise intervention is both feasible and safe for patients with advanced lung or pancreatic cancer. This intervention appears to enhance functional capacity, specific aspects of QoL, and contribute to maintaining body weight.

Exercise and Bone Health in Cancer: Enemy or Ally?

Bone health is often threatened in cancer patients. Bone metastasis and osteoporosis frequently occur in patients with cancer and may lead to different skeletal-related events, which may negatively affect patients' quality of life and are associated with high mortality risk. Physical exercise has been recognized as a potential adjunctive strategy in the cancer setting to improve physical function as well as treatment-related side effects. Nevertheless, exercise is often not recommended to patients with bone health impairments due to safety concerns. In the current review, we aimed, through a comprehensive review of the evidence, to explore the impact of exercise in terms of safety profile, bone outcomes, and the effects on other outcomes in patients with cancer affected by bone metastasis or at high risk of losing bone. Additionally, we explored the potential mechanisms by which exercise may act on bone, particularly the impact of mechanical load on bone remodeling. Finally, considerations about exercise prescription and programming in these populations are also discussed.

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.

Selpercatinib in RET-fusion positive metastatic non-small cell lung cancer: achievements and gray areas.

INTRODUCTION: Selpercatinib is a RET selective tyrosine kinase inhibitor with nanomolar potency against diverse RET alterations, including fusions, activating point mutations, and acquired resistance mutations. Rearranged during transfection (RET) gene is a validated target in non-small-cell lung cancer (NSCLC). Selpercatinib is currently approved for adult patients with metastatic RET fusion-positive NSCLC. AREAS COVERED: This review summarizes the efficacy and safety data of selpercatinib in the treatment landscape of RET fusion-positive NSCLC. EXPERT OPINION: Globally considered, selpercatinib is an optimal treatment choice, in terms of both (systemic and intracranial) efficacy and safety, in patients affected by advanced NSCLC harboring RET fusions as a driver mechanism. Future challenges include the identification of the most appropriate placement for selpercatinib in the treatment algorithm of RET fusion-positive NSCLC (including early stages), the clarification of resistance mechanisms, as well as of its role in EGFR-mutant NSCLC undergoing progression during osimertinib driven by RET alterations.

Effect of exercise on functional capacity in patients with advanced cancer: A meta-analysis of randomized controlled trials.

PURPOSE: To determine the impact of exercise on functional capacity, measured through the "Six minutes walking test" (6MWT) in patients with advanced cancer stage. METHODS: Systematic research on PubMed, Cochrane Library, and SportDiscus was conducted. Randomized controlled trials were eligible if they examined the effect of exercise on 6MWT. RESULTS: Overall, a total of ten trials were included in the primary analysis. Compared to the controls, the exercise intervention was associated with an increase in functional capacity (+20.86 m; CI: -5.90 to 47.72, p = 0.12) although not reaching the statistical significance. Sensitivity analysis revealed an improvement for studies proposing a supervised exercise intervention towards the statistical significance. Few adverse events were associated with exercise training, and the median withdrawals rate was 17%. CONCLUSIONS: Exercise may have a beneficial role on functional capacity in patients with advanced cancer, especially if supervised.

Integrating supportive care into the multidisciplinary management of lung cancer: we can't wait any longer.

INTRODUCTION: Due to important achievements in terms of diagnostic and therapeutic tools and the complexity of the disease itself, lung cancer management needs a multidisciplinary approach. To date, the classical multidisciplinary team involves different healthcare providers mainly dedicated to lung cancer diagnosis and treatments. Nevertheless, the underlying disease and related treatments significantly impact on patient function and psychological well-being. In this sense, supportive care may offer the best approach to relieve and manage patient symptoms and treatment-related adverse events. AREAS COVERED: Evidence reports that exercise, nutrition, smoking cessation, and psychological well-being bring many benefits in patients with lung cancer, from both a physical and socio-psychological points of view, and potentially improving their survival. Nevertheless, supportive care is rarely offered to patients, and even less frequently these needs are discussed within the multidisciplinary meeting. EXPERT OPINION: Integrating supportive care as part of the standard multidisciplinary approach for lung cancer involves a series of challenges, the first one represented by the daily necessity of specialists, such as kinesiologists, dietitians, psycho-oncologists, able to deliver a personalized approach. In the era of precision medicine, this is an essential step forward to guarantee comprehensive and patient-centered care for all patients with lung cancer.

Gastrointestinal Cancer Patient Nutritional Management: From Specific Needs to Novel Epigenetic Dietary Approaches.

Nutritional habits impinge on the health of the gastrointestinal (GI) tract, contributing to GI disorder progression. GI cancer is a widespread and aggressive tumor sensitive to nutritional changes. Indeed, specific nutritional expedients can be adopted to prevent GI cancer onset and to slow down disease activity. Moreover, the patient's nutritional status impacts prognosis, quality of life, and chemotherapy tolerance. These patients encounter the highest frequency of malnourishment risk, a condition that can progressively evolve into cachexia. Clinical studies dealing with this topic stressed the importance of nutritional counseling and put under the spotlight nutrient delivery, the type of nutrient supplementation, and timing for the start of nutritional management. A medical practitioner well-prepared on the topic of nutrition and cancer should operate in the clinical team dedicated to these oncological patients. This specific expertise needs to be implemented as soon as possible to adopt nutritional interventions and establish a proper patient-tailored dietary regimen. The nutritional gap closure should be prompt during anticancer treatment to stabilize weight loss, improve treatment tolerability, and ameliorate survival rate. Recently, novel nutritional approaches were investigated to target the bidirectional link between epigenetics and metabolism, whose alteration supports the onset, progression, and therapeutic response of GI cancer patients.

Nutritional support in lung cancer: Time to combine immunonutrition with immunotherapy?

Although there is substantial evidence on the impact of nutritional-status deterioration on quality of life, treatment tolerance, morbidity, and mortality in people with cancer, clinical nutrition intervention trials in oncology are still limited. The rationale for deepening this topic is also justified by the availability of innovative treatment options, such as immunotherapy, which take into consideration potential modulation of the immune system by several factors. In this article, we aimed to focus on the unexplored issue of immunonutrition and its potential modulatory activity on treatment response in people receiving immunotherapy. With this perspective, we propose a clinical-trial model to explore the potential impact of immunonutrition on nutritional, functional, immunologic, safety, and efficacy parameters in people with advanced non-small cell lung cancer undergoing first-line immunotherapy-based anticancer treatment.