Cachexia induced by GI cancer. Cachexia
Conditions
Interventions
Intervention 1: Intervention group: The intervention group, who suffer from cachexia caused by gastrointestinal cancer, received the standard treatment of Megestrol Acetate 320 mg daily in the form of
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age =18 years GI cancer (any stage) Cachexia (defined loss of >5% of body weight over past 3-6 months, or loss of >2% of body weight over past 2 months or body mass index [BMI] 4 months Patients were allowed to receive systemic anti-cancer treatment, radiation therapy, palliative treatment or supportive care
Exclusion criteria
Exclusion criteria: Mechanical obstruction of the gastrointestinal tract Clinical ascites, and/or generalized edema Severe hepatic (Child-Pough C ) Uncontrolled diabetes Uncontrolled blood pressure (SBP=140 mmHg ? DBP= 90 mmHg ) Chronic heart failure(NYHA class 3 or 4 and/or ejection fraction =35 % Previous history of allergy to Mirtazapine or Megestrol Acetate History of thromboembolic disease History of moderate and severe depression (Hospital Anxiety and Depression Scale –Depression Questionnaire>10 History of seizure Treatment with antidepressant or antipsychotic agents for 30 days prior to or during protocol therapy(a wash-out period of at least 4 weeks prior to study entry was allowed) Intake of supplements or medications that may stimulate appetite (e.g. antipsychotic second generation, Gabapentin, and Pregabalin) Pregnant or lactation women Unstable angina History of stroke Uncontrolled cardiac arrhythmias Confirmed history of gastrointestinal ulcers in such a way that an endoscopy was performed for the patient following gastrointestinal symptoms and a definite diagnosis of gastrointestinal ulcer was made, or a history of gastrointestinal bleeding. Simultaneous use of alpha 2 Agonists, Azalastine, Buprenorphine, Dapoxetine, Hydroxyzine, Linezolid, MOIs [Monoamine oxidase inhibitors], Oxycodone, Methadone Lack of consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain. Timepoint: Primary outcomes will measured at baseline and end of week 4 and end of week 8 of mirtazapine/placebo use. Method of measurement: Scale with precision of 0.1 Kg.;Quality of life. Timepoint: Primary outcomes will measured at baseline and end of week 4 and end of week 8. Method of measurement: EORTC QLQ-C30 questionnare. | — |
Secondary
| Measure | Time frame |
|---|---|
| Appetite. Timepoint: At baseline, end of week 4th and end of week 8th. Method of measurement: Simplified Nutritional Appetite Questionnaire.;Improve of patients' mood. Timepoint: At baseline, end of week 4 and end of week 8. Method of measurement: Hospital Anxiety and Depression Scale.;Improvement of neuropathic pain caused by the use of chemotherapy drugs. Timepoint: At baseline, end of week 4 and end of week 8. Method of measurement: Numeric pain rating scale, Neuropathy pain scale.;Severity of adverse Events. Timepoint: At baseline, end of week 4 and end of week 8. Method of measurement: National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.;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.;CRP. Timepoint: 2 month from baseline. Method of measurement: ELISA. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim salehifar
Mazandaran University of Medical Sciences
Outcome results
None listed