Actively Recruiting
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
Led by OHSU Knight Cancer Institute · Updated on 2026-01-21
66
Participants Needed
1
Research Sites
128 weeks
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
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).
CONDITIONS
Official 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...
- Willing to provide written informed consent
- Age 18 years or older
- Histologically confirmed advanced or metastatic esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosed within 12 weeks before screening
- Weight loss of at least 5% over the past 6 months, or at least 2% weight loss with BMI under 20 kg/m2 or muscle loss (sarcopenia)
- Planned or ongoing first-line palliative cancer therapy (chemotherapy, targeted therapy, immunotherapy, or combinations) with or without radiation, not having started the second cycle
- Able to walk independently with or without assistive devices like a cane or walker
- If brain metastases are present, they must be asymptomatic or treated, with recovery from radiation or surgery effects, off corticosteroids, and neurologically stable for at least 4 weeks
- ECOG performance status of 0 to 2
- Able and willing to stop any drugs or supplements that might interact with the study drug before and during the study
- Willing to follow restrictions on chest/breastfeeding
- If capable of childbearing or contributing sperm, willing to follow contraception rules and not donate ova or sperm during the study and for 1 month afterward
- Negative pregnancy test at baseline for those capable of childbearing
You will not qualify if you...
- Use or planned use within 30 days of antipsychotic drugs like risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, except certain antiemetics
- Use of appetite-enhancing medications or supplements within 14 days before the study, such as megestrol acetate, cannabinoids, or corticosteroids above 5 mg prednisone equivalent daily, except standard chemotherapy nausea prevention
- Poorly controlled diabetes (fasting blood sugar above 300 mg/dL or hemoglobin A1c 8 or higher)
- Severe liver or kidney problems, including high liver enzymes or bilirubin, or kidney disease requiring dialysis or low glomerular filtration rate
- Tube feeding or parenteral nutrition at screening
- Conditions affecting oral drug absorption like swallowing difficulties, mucositis, gastrectomy, bowel obstruction, or planned interventions causing these
- Recurrent ascites needing therapeutic paracentesis
- Uncontrolled symptoms or infections at enrollment, including COVID-19
- Other medical or psychiatric conditions that increase risk or are judged unsuitable by the investigator, including recent or active suicidal thoughts or behavior
AI-Screening
AI-Powered Screening
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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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