Status:
COMPLETED
Olanzapine Anorexia Cachexia
Lead Sponsor:
Cairo University
Conditions:
Anorexia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 Sc...
Detailed Description
This is a placebo-controlled double-blinded phase III randomized clinical trial. One hundred and sixty-four adult incurable cancer patients under treatment at Kasr Al-Ainy Center of Clinical Oncology ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05243251
Start Date
December 25 2021
End Date
December 14 2022
Last Update
October 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine
Cairo, Egypt, 11562