Advanced Malignant Solid Neoplasm Clinical Trial
Official title:
ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
This phase II trial tests how well olanzapine may work in managing cancer cachexia in patients experiencing advanced solid tumor cancer-associated appetite loss while receiving non-curative cancer therapy. Loss of appetite ("anorexia") in the setting of cancer is a key feature of "cachexia," a syndrome associated with loss of weight and muscle as well as weakness and fatigue. Olanzapine is a type of drug that targets key neurotransmitters (a type of molecule used by the brain to transmit messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life.
PRIMARY OBJECTIVE: I. To assess the effect of olanzapine versus placebo for decreasing cancer-associated anorexia at 2 weeks for patients with advanced cancer receiving systemic therapy. SECONDARY OBJECTIVE: I. To evaluate the longitudinal impact of olanzapine versus placebo over 6 weeks on food intake, anthropometric measures, physical function, patient-reported symptoms, quality of life, toxicity, and healthcare utilization. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive 5mg of olanzapine orally (PO) nightly for six weeks on study. Patients may also undergo an optional computed tomography (CT) scan and blood sample collection on the study. ARM II: Patients receive placebo PO nightly for six weeks and then receive 5mg of olanzapine PO nightly for 6 weeks (i.e., wait-list control). Patients may also undergo an optional CT scan and collection of blood samples on the study. ;
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