Cancer anorexia / cachexia syndrome in patients with advanced tumors of different sites MedDRA version: 12.1 Level: LLT Classification code 10064015 Term: Cancer cachexia
Conditions
Interventions
Trade Name: CARNITENE
Pharmaceutical Form: Oral solution
INN or Proposed INN: Levocarnitine
Concentration unit: U/g unit(s)/gram
Concentration type: equal
Concentration number: 2-
Trade Name: CELEBRE
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged = 18 years - Tumor of different site with advanced stage of disease histologically confirmed - Loss of > 5% of ideal body weight or pre-disease in the previous 3 months and pathological values of pro-inflammatory cytokines predict the onset of clinical cachexia - Life expectancy = 4 months - Patients could be receiving concurrent anticancer chemotherapy or hormone therapy with palliative intent or only supportive treatments. - Written informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Significant comorbidity - Women of childbearing age; - Mechanical obstruction to food; - Concomitant medical treatments that could induce a significant change in metabolism or body weight; - A history of venous thromboembolism or bleeding. - Patients with underlying conditions which contraindicate taking MPA, eg patients with a history of thromboembolism, seizures, diabetes. - A history of cardiac disease as severe heart failure (class III or IV New York Heart Association Functional Class), or ejection fraction = 35%, uncontrolled hypertension (systolic> 140 mmHg and diastolic blood pressure> 90 mmHg) , previous myocardial infarction, unstable angina, coronary revascularization, uncontrolled arrhythmia, congestive heart failure - A history of cerebrovascular events, gastrointestinal inflammatory disease and gastrointestinal ulcers - Patients with diabetes - Patients with neutrophil counts less than 1500 mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess which treatment is most effective and safe in inducing an improvement of primary parameters of CACS (increased LBM, decreased REE, improved fatigue) between two arms of approach / combined treatment of cancer cachexia.;Secondary Objective: ;Primary end point(s): 1) change in LBM, assessed through the following methods: - With Dual Energy X-ray absorptiometry (DEXA) using a Hologic Delphi W scanner (Hologic Inc., Bedford, MA); - Computed tomography of the third lumbar vertebra (L3-CT), currently considered the most accurate method in the evaluation indices of lean body mass and muscle in patients with cancer cachexia. Centers are unable to carry out these methods and do have a bioimpedenziometro the LBM will be assessed by BIA. 2) changes in REE, as assessed by indirect calorimetry (Medgem, SensorMedics Italy Srl, Milan, Italy) 3) changes in fatigue symptoms through the MFSI-SF questionnaire (Multidimensional Fatigue Symptom Inventory-Short Form) (45) 4) The total daily physical activity and energy expenditure associated determined through a computerized portable metabolic monitor (SenseWear PRO2 armband, SensorMedics Italy, Milan, Italy). | — |
Countries
Italy
Outcome results
None listed