Evaluation of the Effect of Megestrol Acetate plus Celecoxib in Combination versus Megestrol Acetate alone in Cachexia Induced by Gastrointestinal Cancers

Objectives: Evaluation of the effect of megestrol acetate plus celecoxib in combination versus megestrol acetate alone in cachexia induced by gastrointestinal cancers Design: Triple blind randomized clinical trial Setting and conduct: 80 eligible patients are randomized into two groups. One group receive megestrol acetate 160 mg BD plus celecoxib 100 mg BD for 2 months. Another group receive megestrol acetate alone 160 mg BD for 2 months. Major Inclusion criteria: age of more than 18 y; Confirmed diagnosis of gastroesophageal or colorectal cancer in any stage; Hope for survival of at least 4 month; More than 5% weight loss in the past 3 to 6 month or more than 5% weight loss in comparison to the weight before disease or a body weight less than 5% of ideal body weight or a BMI (Body Mass Index) of less than 20; Palliative treatments or chemotherapy is allowed Major Exclusion criteria: Mechanical obstruction in alimentary tract; Any treatment which induce weight gain like glucocorticoids; Diagnosis of diabetes mellitus with concomitant insulin therapy; Uncompensated cardiac failure with ejection fraction of less than 30% or with New York Heart Association function class of 3 or 4; Uncontrolled Hypertention with systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg; History of myocardial infarction; History of unstable angina; History of Cerebro-vascular accidents; Uncontrolled cardiac dysrhythmias ; Inflammatory bowel disease; gastrointestinal ulcers Intervention: megestrol acetate plus celecoxib in combination versus megestrol acetate alone in cachexia induced by gastrointestinal cancers Outcome measures (variables) : Body weight, Quality of life, Appetite, Markers of inflammatory response including Interleukin-1, Interleukin-6, Tumor necrotizing factor-alpha and Glasgow prognostic score (GPS) will be measured at base line and at the end of study period.

Mazandaran University of Medical Scienses