A phase III randomized trial comparing two regimens for treatment of cancer anorexia / cachexia syndrome(CACS). - ND

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI0 个研究点开始时间: 2010年6月15日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI