RecruitingPhase 2NCT05705492

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer

ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia


Sponsor

OHSU Knight Cancer Institute

Enrollment

66 participants

Start Date

Jul 17, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether olanzapine — a medication typically used for psychiatric conditions but also known to stimulate appetite — can help reverse cancer-related weight loss and poor appetite in people with advanced cancers of the stomach, esophagus, liver, pancreas, bile ducts, colon, or lung. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic cancer of the esophagus, stomach, liver, pancreas, bile ducts, colon/rectum, or lung - You have lost at least 5% of your body weight in the past 6 months, or at least 2% with a low BMI - You are starting or already on first-line palliative cancer treatment - You can walk and move around independently - Your ECOG performance status is 0–2 **You may NOT be eligible if...** - You are past your first cycle of palliative treatment - You have uncontrolled brain metastases or are on corticosteroids for brain swelling - You are taking other medications that could interact with olanzapine - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlanzapine

Given PO

DRUGPlacebo Administration

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

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NCT05705492


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