1294TiP Olanzapine for anorexia in cancer cachexia patients: A placebo-controlled randomized trial

Abstract

Cancer-associated cachexia (CAC) is a complex multifactorial syndrome. Various antipsychotics have been associated with weight gain, especially olanzapine (OLZ) which is suggested to have a role in the management of CAC. It remains unclear whether OLZ has an ameliorating effect on cancer patients’ anorexia, even when those patients exhibit no nausea or vomiting. Given the potential effect of OLZ on CAC and the mixed findings regarding this subject, the current trial aims at evaluating the efficacy of OLZ as a monotherapy in incurable cancer patients with cancer cachexia-associated anorexia. This is a single institution double-blind placebo-controlled randomized clinical trial. One hundred and sixty-four patients are being recruited from December 2021. The trial includes adult patients with incurable solid tumor, CAC, loss of appetite (≥4 score on the 0 to 10 loss of appetite scale of the Edmonton Symptom Assessment System [ESAS]), Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and a predicted survival >3 months. Causes for exclusion are: highly emetogenic chemotherapy, antipsychotic or appetite stimulant administration, nausea or vomiting score >3 on the 0 to 10 scale of the ESAS, weight gain for a known cause (e.g., oedema) or central nervous system disease. Participants will be 1:1 randomized to the intervention arm (OLZ 5 mg tablet once a night for 28 days) or the control arm (placebo tablet once at night for 28 days). The primary endpoint is the change in the loss of appetite score on the 0 to 10 scale of the ESAS from day 0 to day 7 of treatment. The secondary endpoints include the change in loss of appetite score from day 0 to days 14, 21 and 28 and the change in quality of life, handgrip strength, body mass index, body weight, lean body mass, fatigue and c-reactive protein level from day 0 to day 28. NCT05243251. Cairo University.