Actively Recruiting
ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
Led by OHSU Knight Cancer Institute · Updated on 2026-01-21
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of olanzapine to manage appetite loss associated with cancer cachexia in patients with advanced or metastatic esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancers. Cachexia is a syndrome involving weight and muscle loss, weakness, and fatigue, often linked to anorexia in cancer patients. This phase II trial aims to assess whether olanzapine can stimulate appetite, improve calorie intake, reduce weight loss, and enhance quality of life while patients receive non-curative cancer therapy. Participants are randomly assigned to one of three groups for 12 weeks: a low dose of olanzapine (2.5 mg), a higher dose of olanzapine (5 mg), or a placebo, all taken orally each night if no unacceptable side effects occur. After this period, participants may continue with the lower dose of olanzapine for an additional 12 weeks. Optional procedures include baseline computed tomography (CT) scans and monthly blood sample collections during the study. During the trial, participants will be assessed for weight change, appetite, nutritional status, physical function, symptoms, quality of life, and healthcare use over 12 weeks. Questionnaires and safety monitoring will take place at baseline and regular intervals. After completing treatment, participants will have a follow-up visit one week later. The study measures the proportion of patients who gain more than 5% of their weight from baseline to 12 weeks as the primary outcome.
CONDITIONS
Brief Title
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to provide written informed consent
- 18 years of age or older
- Histologically confirmed advanced local or metastatic esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening
- Weight loss as defined by international criteria: at least 5% weight loss over the past 6 months, or at least 2% weight loss with BMI below 20 kg/m2 or sarcopenia
- Planned or ongoing first-line palliative antineoplastic therapy (chemotherapy, targeted therapy, immunotherapy, or combinations) without starting the second cycle
- Able to walk independently with or without assistive devices
- For brain metastases, asymptomatic or treated with recovery from radiation or surgery and stable for at least 4 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Willing and able to stop any drugs or supplements that may interact with the study drug
- Willing to comply with chest/breastfeeding restrictions
- Individuals capable of childbearing and contributing viable sperm must agree to contraception and not donate ova or sperm during and 1 month after the study
- Negative pregnancy test at baseline for those capable of childbearing
You will not qualify if you...
- Use or planned use of antipsychotic drugs within 30 days before enrollment, except certain antiemetics
- Use of appetite-enhancing medications or supplements within 14 days before enrollment, including megestrol acetate, cannabinoids, or corticosteroids above 5mg prednisone equivalent except for nausea prevention
- Poorly controlled diabetes with fasting blood sugar above 300 mg/dL or recent hemoglobin A1c of 8 or more
- Inadequate organ function with elevated liver enzymes or bilirubin beyond set limits unless specific exceptions apply
- Kidney disease requiring dialysis or low glomerular filtration rate (GFR 30 mL/min/1.73 m2 or less)
- Receiving tube feeding or parenteral nutrition at screening
- Conditions affecting oral absorption of the study drug or planned interventions causing such conditions
- Recurrent ascites requiring frequent medical drainage
- Uncontrolled symptoms at randomization unless effectively managed for at least one week
- Uncontrolled infection including COVID-19 at randomization
- Medical or psychiatric conditions including recent or active suicidal thoughts or behaviors that increase risk or make participation inappropriate in the investigator's judgment
- Use of antipsychotic drugs concurrent with study therapy not allowed during the trial period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive nightly oral doses of olanzapine or placebo for 12 weeks. They may optionally undergo computed tomography (CT) scans and monthly blood sample collections during this period.
Monthly visits for CT scan and blood sample collection; daily dosing at home
Duration - 12 weeks
Participants may choose to continue nightly olanzapine 2.5 mg orally for an additional 12 weeks with optional monthly blood sample collections.
Monthly visits for blood sample collection; daily dosing at home
Duration - 1 week
Participants are followed up 1 week after completing study treatment to assess safety and recovery.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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