Effect of Megestrol Acetate plus Celecoxib versus Megestrol Acetate alone in Cachexia

Phase 3

• Conditions: Cachexia.; Cachexia

• Registration Number: IRCT201407222027N4
• Lead Sponsor: Mazandaran University of Medical Scienses

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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
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 than140 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 or history of GI bleedings

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: 2 month from baseline. Method of measurement: EORTC QLQ-C30 questionnare.;Weight. Timepoint: 2 month from baseline. Method of measurement: Scale with precision of 0.1 Kg.

Secondary Outcome Measures

Name	Time	Method
Glasgow prognostic score (GPS). Timepoint: 2 month from baseline. Method of measurement: calculated based on Albumin and CRP.;IL-1. Timepoint: 2 month from baseline. Method of measurement: ELISA.;IL-6. Timepoint: 2 month from baseline. Method of measurement: ELISA.;TNF-alpha. Timepoint: 2 month from baseline. Method of measurement: ELISA.;Appetite. Timepoint: 2 month from baseline. Method of measurement: Visual analogue scale.