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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201407222027N4
Enrollment
80
Registered
2016-09-11
Start date
2015-10-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia. Cachexia

Interventions

Intervention 1: Megestrol acetate 160mg BD+Celecoxib 100mg BD for 2 months in intervention group. Intervention 2: Megestrol acetate 160mg BD for 2 months in control group.
Treatment - Drugs
Megestrol acetate 160mg BD+Celecoxib 100mg BD for 2 months in intervention group
Megestrol acetate 160mg BD for 2 months in control group

Sponsors

Mazandaran University of Medical Scienses
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Salehifar

Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences

Esalehifar@mazums.ac.ir ; salehifare@yahoo.com+98 113543241

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026