164 patients will be recruited..Adult patients diagnosed with incurable solid tumors and CCAA who presented to Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK) - Kasr Al-Ainy School of Medicine - Cairo University will be randomly distributed into 1:1..82 will receive Olanzapine 5 mg daily at night and 82 patients will receive placebo for 4 weeks. Primary outcome is Change in loss of appetite score from day 0 to day 7 of treatment and secondary outcomes change in body weight, change in loss of appetite score..and change in quality of life
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* o Age ≥ 18 years old at time of informed consent
* Confirmed diagnosis of incurable solid tumor (cancer patients with incurable disease receiving anti-cancer therapy with palliative intent or best supportive care).
* Loss of appetite score ≥ 4 on a 0 to 10 loss of appetite scale where 10 = worst possible lack of appetite as assessed by the Arabic version of Edmonton Symptom Assessment Scale (R/ESAS r) (ESAS-r, 2021).
* Cachexia defined as "loss \> 5% of body weight over the last 6 months" or "any degree of weight loss \> 2 % associated with a body mass index (BMI) \< 20" (Fearon et al, 2011).
* Ability to take pills orally and not dependent on tube feeding (no oral mucosal inflammation, active dysphagia or gastrointestinal tract obstruction).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Ability to understand and communicate in Arabic and willingness to sign a written informed consent.
* Patients were allowed to receive three-weekly regimens of anti-cancer treatment with palliative intent except those containing highly emetogenic chemotherapeutic (HEC) agents/regimens according to the American Society of Clinical Oncology (Hesketh et al, 2020).
* Clinically-predicted survival of \> 3 months.
* Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).
Exclusion Criteria:
* o Weight gain for known cause, e.g. oedema or ascites.
* Treatment with other antipsychotic …