Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Obesity

Malnutrition

Sarcoma

Sarcopenia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Nutrition Disorders

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Soft Tissue Sarcoma

Subgroup of patients with available preoperative CT/MRI scans will be detected and body composition measurements will be assessed min order to detect nutrition-related syndromes

The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)

Measurement of body composition with computed tomography (CT)

GLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition

GLIM malnutrition criteria

EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia

EWGSOP2 sarcopenia criteria

The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity

ESPEN-EASO criteria for sarcopenic obesity

Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count

Prognostic Nutritional Index (PNI)

The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin

The high-sensitivity modified Glasgow prognostic score

Manuel Ramanović, M.D.

Nada Rotovnik Kozjek, M.D. PhD

Marko Novak, M.D.

Andraž Perhavec, M.D. PhD

Taja Jordan, M.D. PhD

This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.

Retroperitoneal sarcomas (RPS) are rare neoplasms of mesenchymal origin with estimated crude incidence of 0.3 cases per 100000 inhabitants per year. The most common histologic subtypes are well-differentiated and dedifferentiated liposarcoma and leiomyosarcoma, accounting for 42% and 26% of cases, respectively. RPS are optimally managed in multidisciplinary settings in specialized sarcoma centers. Surgical resection with an adequate margin of normal tissue is the cornerstone of curative therapy and en bloc surgical resection of localized tumors is the recommended surgical approach. This "extended" surgical approach (including resection of adjacent organs), is optimal for reducing local recurrence and improving overall survival.

Cancer patients undergoing surgical treatment face number of challenges which negatively impact their nutritional status. Patients are usually in catabolic state, which together with ongoing proteolysis and lipolysis as well as decreased protein synthesis contribute to development of cancer - associated cachexia. Most important nutritional disorders in these patients are malnutrition, sarcopenia, cancer cachexia. On the other side, often under-recognized, sarcopenic obesity is gaining attention in clinical and research settings.

The association of malnutrition and poor postoperative outcome has been demonstrated in patients with various cancer locations. Malnourished patients reportedly have longer length of postoperative stay (LOS), higher rates of 30-day mortality, infection rate, sepsis, reoperation, increased number of cardiopulmonary complications. Diagnostic process of malnutrition has been a topic of debate considering inconsistency in diagnostic methodology and criteria. Global Leadership Initiative on Malnutrition (GLIM) addressed this problem and recommended a new diagnostic scheme for malnutrition, in form of consensus report incorporating previous finding and recommendations from world leading clinical nutrition societies. To our knowledge, no study validated GLIM criteria in patients with primary RPS.

Sarcopenia is clinical syndrome characterized by generalized skeletal muscle mass loss, loss of strength and function (performance). Sarcopenia has been associated with lower survival rate and proved to be an independent predictor of survival in patients with breast cancer, pancreatic adenocarcinoma, hepatocellular carcinoma, and melanoma. There is a lack of studies investigating the impact of sarcopenia on survival and postoperative outcome in patients with soft-tissue sarcoma (STS), including retroperitoneal sarcoma. Similarly to malnutrition diagnosis, there is an evident inconsistency and confusion in diagnostic criteria and tools used to define and characterize sarcopenia in clinical practice and research. However, recently the European Working Group on Sarcopenia in Older People (EWGSOP2) published updated findings in form of Revised European Consensus. The Working Group proposed new recommendation, among which are those related to establishing specific cut-off points for body composition (primarily skeletal muscle quantity and quality) measures that identify and characterize sarcopenia.

Sarcopenic obesity (SO) is co-existence of sarcopenia and excess adiposity. Recent expert consensus of The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) will be followed for definition and diagnostic criteria for SO.

Myosteatosis is ectopic adipose tissue infiltration in skeletal muscle. Intermuscular adipose tissue can be quantified using CT scans by low muscle radiodensity. CT-derived myosteatosis contributes to impaired glucose metabolism, including insulin resistance, type 2 diabetes mellitus, and inflammation. Additionally, it may increase the risk for dyslipidemia. Myosteatosis may predict oncologic and postoperative outcome in primary RPS patients.

Patients with primary RPS are in a great risk for malnutrition, sarcopenia and cachexia for the number of reasons: requirement for demanding abdominal surgery in their management, catabolic tumor effects, long period before diagnosis of RPS and tumor size (approximately 15 cm). Due to their rarity, it is still unclear how preoperative nutritional status and body composition impact outcome of patients with primary RPS.

STUDY DESIGN DATA COLLECTION Patient's histories including the anaesthetician's preoperative reports, surgeon's operative reports, hospital records, and follow-up data will be collected. Paper and electronic data archive of Institute of Oncology Ljubljana Patient Data Information System will be used.

The following preoperative clinical data will be acquired: age, sex, preoperative weight, height, significant weight loss, appetite loss and weakness. CT reports will be also acquired for analysis as well as histopathological diagnosis (subtype), stage, grade and tumor size.

The preoperative laboratory data, including absolute counts of leukocytes, neutrophils, lymphocytes, monocytes and platelets, CRP, and albumin levels will be assessed. Data will be deidentified and whenever possible all measures to conceal patient identifiers and maintain patient confidentiality will be taken.

STATISTICAL CONSIDERATIONS The data will be presented using appropriate summary statistics: mean, median, standard deviation for continuous variables and percentages and frequencies for categorical variables. Kaplan-Meier method will be used for survival curves analysis and differences between survival rates compared using the log-rank test. The independent prognostic variables for survival (OS and LRFS) will be identified using Cox proportional hazard model (hazard ratio, 95% confidence interval, p value).

ETHICS The study was approved by Slovenian National Medical Ethics Committee, Institute of Oncology Ljubljana Review Board and Institute of Oncology Ljubljana Ethical Committee. The need to obtain informed consent from participants was waived.

Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma

Influence of Body Composition, Nutritional Status and Inflammatory Markers on Survival and Postoperative Outcome in Patients Operated on for Primary Retroperitoneal Sarcoma: Report From Institute of Oncology Ljubljana

Complications graded by Clavien-Dindo Complication Classification System

A postoperative local recurrence will be defined by biopsy-proven or radiographic evidence of local recurrent disease

Overall survival (OS) will be defined as the time between the date of the operation to the date of death from any cause or last follow-up (according to medical records and using telephone contacts)

Time interval from the date of operation to the date of discharge. Body composition parameters may predict the length of hospital stay

Complication grade 3 or higher according to Clavien-Dindo Complication Classification System

A prevalent case of malnutrition will be considered if a patient fulfills the Global Leadership Initiative on Malnutrition (GLIM) criteria. GLIM proposed 5 diagnostic criteria to assess malnutrition and includes 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation/disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present

A prevalent case of sarcopenia will be considered if a patient fulfills the diagnostic criteria defined by European Working Group on Sarcopenia in Older People (EWGSOP2)

Skeletal muscle area (SMA) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm\^2 using standard Hounsfield Unit thresholds of - 29 to + 150. SMA at the third lumbar spine level has been established as a good indicator of whole-body muscle mass.

Muscle radiation attenuation (MRA) will be assessed using CT scans at lumbar (L3) vertebral level and recorded as mean Hounsfield unit (HU) of each pixel within a region of interest. MRA reflects muscle composition, including the degree of intramuscular fat accumulation, important to define the presence of myosteatosis

Visceral adipose tissue (VAT) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm\^2 using standard Hounsfield Unit thresholds of -150 to -50

Subcutaneous adipose tissue (SAT) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm\^2 using standard Hounsfield Unit thresholds of -190 to -30.

Visceral-to-subcutaneous adipose tissue ratio will be calculated by dividing the visceral adipose tissue area by the subcutaneous adipose tissue area.

Neutrophil to lymphocyte ratio (NLR): calculated as the absolute neutrophil count divided by the absolute lymphocyte count.

Platelet to Lymphocyte Ratio (PLR): calculated as the absolute platelet count divided by the absolute lymphocyte count.

Systemic immune inflammation index (SII): based on absolute platelet, neutrophil and lymphocyte count and calculated according to following formula:

SII =(platelet count×neutrophil count)/(lymphocyte count)

The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) will be defined as numeric value 0 - 2 according to following criteria based on C-reactive protein (CRP) and serum albumin levels:

Score 0: CRP level ≤ 0.3 mg/dl and albumin ≥ 3.5 g/dl, Score 1: CRP level \> 0.3 mg/dl and albumin ≥ 3.5 g/dl, Score 3: CRP level \> 0.3 mg/ dl and albumin \< 3.5 g/dl.

The prognostic nutrition index (PNI) will be calculated based on previously published and validated formula:

PNI =10× serum albumin (g/dl)+0.005× lymphocyte count (per mm\^3)

Institute of Oncology Ljubljana

Digestive System Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Stomach Neoplasms

Obesity, Abdominal

Overweight

Overnutrition

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Esophageal Cancer

Quality of Life

Stomach Cancer

Esophagectomy or Gastrectomy

John V Reynolds, MCh FRCS

In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy.

The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible.

The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.

Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer

An Investigation of the Prevalence and Clinical Impact of Sarcopenia and Visceral Obesity Among Patients With Upper Gastrointestinal Malignancies

St. James's Hospital, Ireland

Clinical Research Fellow

Blood and Lymph Conditions

Immune System Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Includes children following a vegetarian diet.

Includes children following a non-vegetarian diet.

Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.

Vegetarian Diet

Michelle Walters, MS, RD

Maya Prasad, MD

Krisha Savla

Elena J. Ladas, PhD, RD

Sarcopenic obesity occurs when there is a loss of muscle and gain of fat in the body. With this study, the investigators will explore how nutritional status at the beginning of the treatment can cause changes in your child's body fat compared to muscle in the body. The investigators will also look at how these changes can impact a child's cancer treatment, survival from treatment, and if there is any deterioration in health and nutrition status. The primary objective of this study is to establish the incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with acute lymphoblastic leukemia (ALL).

Survival of childhood ALL exceeds 80% in an increasing number of many low-middle income countries (LMIC). Recent studies have found that the effects of obesity on survival are observed within the first several years of diagnosis, thus impacting immediate health outcome. Of concern is the developing body of evidence that the effects of obesity may be underestimated and its effect on outcome may be even more pronounced when it is defined by body composition. An elevated body mass index (BMI) can be comprised of increased fat-free mass (FFM) or fat-mass (FM) or a combination of both. Evidence suggests that an increase of FM is a stronger predictor of risk of chronic disease rather than BMI. The evaluation of FM and FFM appears to have clinical implications in both adult and pediatric oncology, particularly in patients with Sarcopenic Obesity (SO) (increased FM and reduced FFM). Among children with ALL located in both high income countries (HIC) and LMIC, remediation of poor nutritional status during treatment removes its adverse effect on survival at the end of treatment. targeting dietary patterns may be a more effective approach when considering dietary interventions. One plausible way to examine the association of dietary patterns with the development of SO in pediatric ALL is to compare a vegetarian diet to a non-vegetarian diet and investigate how they are associated with its development. Children and adolescents with ALL at Tata Memorial Center (TMC) are well suited for this investigation because at least 30% of children follow a vegetarian diet, are easily identified, and the diets are not interchangeable. The benefit of the proposed model eliminates the need for dietary intervention prior to the study, which will examine how SO, accumulation of FM and the loss of FFM, develops among children and adolescents with ALL adhering to a vegetarian compared to non-vegetarian diet. Additionally, this study will examine the interaction of physical activity and diet while considering influential variables on the development of SO.

Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia

Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia: A Pilot Study

Incidence of sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA), among Indian children and adolescents with ALL.

Association of a vegetarian compared to a non-vegetarian diet and sarcopenic obesity, measured by dual-energy x-ray absorptiometry (DEXA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma	NCT05631379	Retroperitoneal... Body Compositio... Malnutrition Sarcopenia Sarcopenic Obes... Myosteatosis	Measurement of ... GLIM malnutriti... EWGSOP2 sarcope... ESPEN-EASO crit... Prognostic Nutr... The high-sensit...	18 Years -	Institute of Oncology Ljubljana
Sarcopenia and Visceral Obesity in Esophageal and Gastric Cancer	NCT03061370	Esophageal Canc... Gastric Cancer Sarcopenia Sarcopenic Obes... Obesity Visceral Obesit... Quality of Life Surgery Complication of... Chemotherapeuti... Physical Activi... Oncology	Esophagectomy o...	18 Years -	St. James's Hospital, Ireland
Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia	NCT03974893	Sarcopenic Obes...	Vegetarian Diet	5 Years - 15 Years	Columbia University
Dietary Intake, Sarcopenic Obesity, and Other Treatment-Related Outcomes in Indian Children With Acute Lymphoblastic Leukemia	NCT03974893	Sarcopenic Obes...	Vegetarian Diet	5 Years - 15 Years	Columbia University
Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma	NCT05631379	Retroperitoneal... Body Compositio... Malnutrition Sarcopenia Sarcopenic Obes... Myosteatosis	Measurement of ... GLIM malnutriti... EWGSOP2 sarcope... ESPEN-EASO crit... Prognostic Nutr... The high-sensit...	18 Years -	Institute of Oncology Ljubljana

Spots Global Cancer Trial Database for sarcopenic obesity