Olanzapine for Appetite Loss in Advanced Cancer
This study is testing if olanzapine, a medication, can help manage appetite loss and weight loss (called cachexia) in people with advanced esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer. Cachexia is a condition that causes weight and muscle loss, weakness, and tiredness. Researchers want to see if olanzapine can help patients gain more than 5% of their body weight over 12 weeks. The study will compare different doses of olanzapine to a placebo (an inactive pill). About 66 people are planned to join this study. To be eligible, you must be at least 18 years old, have one of these advanced cancers, and have experienced weight loss.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 66 participants and compares olanzapine to a placebo.
- What's involved
- Participants will take olanzapine or a placebo by mouth nightly for 12 weeks. There are optional monthly blood sample collections and optional CT scans at the beginning of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures weight gain from baseline to 12 weeks. Some participants may choose to continue treatment for an additional 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05705492
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalSupportive careOHSU Knight Cancer InstituteInvestigator-initiated
~66 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:OlanzapinePlacebo AdministrationQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients exhibiting weight gain greater 5%
Measured over Baseline to 12 weeks from baseline
Conditions
Where it's being run
1 sites across 1 statesOregon1
Study leadership
- Eric Roeland, M.D., FAAHPM, FASCO · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening
Able to ambulate independently with or without assistive devices (e.g., cane, walker)
In the case of brain metastases, the individual must be asymptomatic or previously treated with a full cycle of therapy with recovery from any acute effects of radiation therapy or surgery before screening. Such individuals must have discontinued corticosteroid treatment and be neurologically stable for at least 4 weeks before screening
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Able and willing to discontinue the use of any drug or over-the-counter (OTC) product that may interact with the study drug (within a period sufficient for wash-out per the principal investigators \[PI's\] discretion) and thereafter while on the study
Willingness to comply with restrictions on chest/breastfeeding
Individuals capable of childbearing and contributing viable sperm must be willing to comply with contraception requirements and not donate ova or sperm while on the study and for 1 month after that
A negative pregnancy test at baseline (BL) must be obtained for individuals capable of childbearing
Exclusion
Plan for, or history of (within 30 days of enrollment), the use of an antipsychotic drug, including, but not limited to, risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone. This limitation does not include prochlorperazine and other phenothiazines as antiemetic therapy. The use of antipsychotics concurrent with protocol therapy will not be allowed
Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including:
megestrol acetate
cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter \[OTC\] cannabinoid products), and/or
Corticosteroids (defined as ≥ 5mg of prednisone \[or equivalent per day\]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis
Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment
Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:
Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SPGT\]) ≥5X ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)
Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN
Renal disease requiring dialysis or calculated glomerular filtration rate (GFR) ≤ 30 mL/minute/1.73 m\^2 as calculated by the modification of diet in renal disease (MDRD) equation
Tube feeding or parenteral nutrition at the time of screening
Any condition that may negatively impact oral absorption of the study drug (including, but not limited to dysphagia, mucositis, gastrectomy, colitis, bowel obstruction, high output ileostomy) or any plan to undergo an intervention that will render such a condition
Recurrent ascites unresponsive to medical interventions and requires therapeutic paracentesis
Uncontrolled symptoms at randomization make the individual unsuitable for the study in the judgment of the PI. If uncontrolled symptoms can be effectively palliated for ≥1 week prior, enrollment may be considered at the discretion of the PI
Uncontrolled infection, including coronavirus disease 2019 (COVID-19), at time of randomization. Individuals with the uncontrolled infection will not be eligible as the symptomology of infection may obscure the outcomes of this study
Other medical or psychiatric condition, including recent (within 1 year) or active suicidal ideation/behavior or laboratory abnormality, may increase the risk of study participation or, in the PI's judgment, makes the participant inappropriate for the study
What this trial measures
- Proportion of patients exhibiting weight gain greater 5%Baseline to 12 weeks from baseline
\>5% weight gain comparing olanzapine 2.5mg (Arm I) vs. placebo (Arm III)