Clinical trial · Interventional
Olanzapine Anorexia Cachexia
Olanzapine in Cancer Cachexia-Associated Anorexia: a Double-Blind Placebo-Controlled Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine 5 MG | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Olanzapine
- description
- 82 patients will receive olanzapine 5 mg daily at night for 4 weeks
- interventionNames
- Drug: Olanzapine 5 MG
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 82 patients will receive placebo for 4 weeks
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- appetite score
- timeFrame
- 1 week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available