Olanzapine in Anorexia Cachexia Syndrome Among Advanced Cancer Patients

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Olanzapine

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.