Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia

Inclusion Criteria:

* Patients with confirmed advanced cancer.
* Patients with appetite score equal or more than 4 on a 0 to 10 scale (10 \_ worst appetite).
* Patients with weight loss more than 5 % of body weight over 6 months . Or : Patients with any degree of weight loss more than 2 % associated with BMI ( body mass index ) of less than 20.
* Patients able to take pills orally and not dependent on tube feeding (no oral mucosal inflammation interfering with oral intake or dysphagia as determined by clinical examination).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).
* Ability to understand and willingness to sign written informed consent.
* Patients could be receiving concurrent chemotherapy or radiation therapy.
* Patients with an expected life span of at least 3 months.

Exclusion Criteria:

* Patients with weight gain for known cause , e.g. , ascites.
* Premenopausal women with childbearing potential with a positive pregnancy test.
* Patients unable to maintain oral intake .
* Patients with dementia or delirium.
* Patients with uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression will be excluded until their symptoms had stabilized for at least 2 weeks.
* Because improvement in anorexia and/or weight in depressed individuals could be due to an antidepressant effect of mirtazapine, rather than to a direct effect on anorexia, patients with moderate to severe depressive symptoms will be also excluded. the screening instrument will be a single-item interview assessing depressed mood of the Schedule for Affective Disorders and Schizophrenia (SADS) instrument which is validated and highly accurate in screening for depression when compared to the gold standard of semistructured diagnostic interviews, and is rated on a 6-point Likert scale, where 0 = no depression and 6 = extreme feelings of depression. Patients with a score of 4 or more will be excluded from the study as they are considered to be at high risk for depression.
* No treatment with antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days prior to or during protocol therapy.
* Patients with untreated vitamin B12 deficiency or endocrine abnormalities that could affect appetite, such as thyroid dysfunction and hypoadrenalism.
* Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide, will be excluded unless they are put on a stable dose for more than 2 weeks and continue to experience poor appetite.