Chemotherapy-induced anorexia in cancer patients. Anorexia
Conditions
Interventions
Intervention 1: Intervention Group: Patients in this group will receive one oral capsule containing 2.5 mg of olanzapine once daily. Olanzapine is an atypical antipsychotic agent with antagonistic eff
Sponsors
Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cancer patients who are candidates for chemotherapy Patients with locally advanced or metastatic breast or gastrointestinal cancers Acceptable physical performance (ECOG-PS between 0 and 3) Ability to take medications orally Signed written informed consent
Exclusion criteria
Exclusion criteria: Concurrent treatment with hormonal therapy, immunotherapy, or oral chemotherapy Long-term use of antipsychotic medications History of allergy or hypersensitivity to olanzapine Use of corticosteroids equivalent to 5 mg or more of prednisolone in the past 7 days Presence of refractory ascites or bowel obstruction at enrollment Pregnancy Refractory nausea and vomiting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight in kilograms. Timepoint: Measurement of body weight at baseline and on day seven after starting the intervention. Method of measurement: Weighing with a calibrated digital scale, without shoes and in light clothing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse effects related to olanzapine such as drowsiness, constipation, or dizziness. Timepoint: Daily monitoring of adverse effects during the 7-day intervention period. Method of measurement: Physician assessment and documentation of adverse effects based on patient report and daily clinical examination.;Change in appetite severity measured by the Visual Analogue Scale. Timepoint: Measurement of appetite severity at baseline (before the intervention) and on day seven after starting the intervention. Method of measurement: Ten-centimeter Visual Analogue Scale to assess appetite severity, with scores ranging from zero (no appetite) to ten (maximum appetite).;Change in daily caloric intake. Timepoint: Recording daily caloric intake at baseline and on day seven after starting the intervention. Method of measurement: 24-hour dietary recall recorded by the patient and analyzed for calories by a nutritionist using diet analysis software.;Change in quality of life score measured by the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Timepoint: Assessment of quality of life at baseline and on day seven after starting the intervention. Method of measurement: Standard QLQ-C30 questionnaire including 30 multidimensional questions on physical function, symptoms, and overall health status. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNegin farshchian
Kermanshah University of Medical Sciences
Outcome results
None listed