Clinical trials

Rationale: One of the greatest challenges in the field of cancer treatment is cachexia, a multifactorial syndrome characterized by substantial loss of body weight (muscle and fat mass), leading to progressive functional impairment. Cancer cachexia significantly impairs quality of life and survival as well as treatment outcome. Despite its considerable relevance for the prognosis of cancer patients, the diagnosis of cachexia is problematic. The current consensus definition of cancer cachexia is based on weight loss over the last six months. In practice, this is assessed by subjective reporting by the patient, which is subject to error and bias. Novel technologies enable accurate, standardized, and objective assessment of body weight and physical activity by newly diagnosed cancer patients in the home situation. Because of the increasing implementation of neo-adjuvant treatment strategies that offer an extended time-window for the collection of these data, there is a great opportunity to use this information in risk analyses by treating physicians, optimization of pre-habilitation programs, and in the shared-decision making process with the patient. Objective: The central aim of the 'Patient-Recorded Indexing MeasurementS' (PRIMS) study is to improve the accuracy of the diagnosis of cachexia in patients with cancer. This aim will be achieved by focusing on two objectives. The primary objectives are to compare self-reported and objectively measured pre-treatment weight change. The secondary objectives are to define host phenotypes and to investigate longitudinal associations between body weight and physical activity patterns. Study design: Explorative pilot study Study population: Patients ≥18 years old undergoing curative-intent chemotherapy or surgery for cancer. Patients will be included in two referral centers specialized in treatment of patients with upper gastrointestinal, hepatobiliary, pancreatic, colorectal, and ovarian cancer. Main study parameters/endpoints: The primary endpoint is body weight change over time. Objectively measured body weight will be compared to subjectively reported body weight change. Their respective association with treatment-related adverse events and survival will be investigated. Survival will be calculated from date of start of treatment until death. Chemotherapy related adverse event will be recorded using the Common Terminology Criteria for Adverse Events. Postoperative adverse events will be scored according to the Clavien-Dindo classification. Secondary endpoints: The secondary endpoints will be the association between other cachexia-related parameters that are investigated in the study and adverse events / survival. Other parameters include physical activity over time, using accelerometry, baseline physical assessment, anthropometric measurements, body composition, and laboratory results. Besides this, other endpoints that will be assessed are disease-free survival (calculated from the first day of treatment until first recurrence) and response to chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

The goal of this study is to evaluate the use of new method to quantify the amount of sugar a tumor consumes using PET/CT. The main questions it aims to answer are: * Is the new quantification method superior with respect to the method currently used in the clinic? * Does the new quantification method provide accurate assessment of the sugar consumption of tumours? Participants who will undergo a standard care FDG PET/CT scan will in additional receive a dynamic PET/CT scan prior to the standard care scan. In addition blood samples will be drawn at three time points during the examination.

Rationale: Complication rates after major liver resections remain as high as 43%. Many initiatives have been taken to reduce postoperative morbidity. As such, prehabilitation programmes are increasingly used for patients undergoing major abdominal surgery. Improvement of aerobic fitness has been proven to reduce complication rates, especially in high-risk patients (those with a low preoperative aerobic capacity). Different conceptual hypotheses exist of the underlying mechanism of variability in postoperative complications and prehabilitation response. One of the complementary rationales focusses on homeostasis-allostasis before and after surgery, more specifically on the preoperative aerobic capacity to meet postoperative metabolic demands. However, more insight in postoperative metabolic demands (energy expenditure) during in-hospital recovery from major abdominal surgery in relation to preoperative resting metabolic demands and maximal aerobic capacity is essential to understand the increase in metabolic demands coinciding with major surgery in relation to the body's reserve capacity. This information can be used to better understand the rationale behind exercise prehabilitation, as well as to optimize the content of preoperative treatment for unfit patients, for instance by means of personalized prehabilitation programs that might improve postoperative outcomes. Objective: This study aims to explore the difference of pre- and postoperative energy expenditure in patients undergoing major elective liver resection and relate this to their preoperative aerobic capacity. Study design: The study will be a prospective observational study with thorough pre- and postoperative measurements of energy expenditure. Energy expenditure will be measured using the doubly labelled water method, as well as by indirect calorimetry. To assess aerobic capacity, cardiopulmonary exercise testing will be performed pre- and postoperatively. Additionally, accelerometers will be used to evaluate pre- and postoperative physical activity levels. Study population: Patients aged ≥18 years undergoing major liver resection (≥3 segments) will be asked to participate. The inability to perform cardiopulmonary exercise testing, neo-adjuvant chemotherapy, and cirrhotic liver are reasons for exclusion. Main study parameters/endpoints: The main study parameter is the difference of energy expenditure pre- and postoperatively, as measured with doubly labelled water and indirect calorimetry. Secondary endpoints: Additionally, as secondary endpoints, aerobic fitness, physical activity level, and postoperative complications will be assessed.

The Southeast Netherlands Advanced Breast Cancer (SONABRE) Registry is a real life multi-center study. The registry aims to include all patients diagnosed with advanced breast cancer as of 2007 in 11 hospitals in the Netherlands. Data on patient, tumor and treatment characteristics are collected retrospectively from electronic medical files by trained registry clerks.