Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05243251
Eligibility Criteria:
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 agents during the past 30 days.
* Hypersensitivity to olanzapine.
* Premenopausal women with childbearing potential with a positive serum B-HCG pregnancy test.
* Inability to maintain oral intake.
* Central nervous system disease (e.g., brain metastases, seizure disorder, schizophrenia, bipolar disorder, dementia or delirium).
* Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide.
* Patients unwilling or unable to comply with the protocol.
* Nausea and/or vomiting score \>3 on a 0 to 10 scale where 10 = extreme nausea/vomiting.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05243251
Study Brief:
Protocol Section:
NCT05243251