ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
OHSU Knight Cancer Institute
Summary
This phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) -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 drug that targets key neurotransmitters (a type of molecule in the central nervous system that transmits messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life (QOL).
Description
PRIMARY OBJECTIVE: I. To assess the impact of olanzapine 2.5 mg versus (vs) placebo on the proportion of patients with locally advanced or metastatic EG, HPB, or lung cancers receiving first-line systemic standard-of-care (SOC) therapy with \>5% weight gain over 12 weeks. (Part A) SECONDARY OBJECTIVE: I. To evaluate the impact of olanzapine 2.5 mg and placebo vs olanzapine 5 mg on the proportion of patients with \>5% weight gain over 12 weeks. (Part A) II. To evaluate the impact of olanzapine 2.5 mg vs olanzapine 5 mg vs placebo on additional cancer cachexia-associated endpoints over 12 wee…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willingness to provide written informed consent * Individuals \>= 18 years of age * Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening * Patients with weight loss as defined by international consensus criteria (documented or patient-reported): * ≥ 5% weight loss over the past 6 months * ≥ 2% weight loss with body mass index (BMI) \<20 kg/m\^2 or sarcopenia * Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted the…
Interventions
- DrugOlanzapine
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- OHSU Knight Cancer InstitutePortland, Oregon