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

• Conditions: Cancer anorexia / cachexia syndrome in patients with advanced tumors of different sites; MedDRA version: 12.1Level: LLTClassification code 10064015Term: Cancer cachexia

• Registration Number: EUCTR2010-019831-36-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-15
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified