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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
- Procedures mentioned: Blood draws, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 weeks (anorexia, nutritional status, physical function, patient-reported symptoms, QOL, safety and toxicity, and healthcare utilization) over 12 weeks. (Part A) OUTLINE: PART A: Patients are randomized to 1 of 3 arms."
- "All three arms have an optional baseline computed tomography (CT) scan (timed with standard-of-care imaging) at baseline and optional monthly blood sample collections."
- "ARM I: Patients receive a lower (2.5 mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity."
- "Patients may choose to participate to undergo CT scan and collection of blood samples on study."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether olanzapine can help with cancer-related appetite loss, weight loss, and muscle loss. It is for adults with advanced cancer of the food pipe, stomach, liver, pancreas, bile system, colon, rectum, or lung who are getting cancer treatment that is not meant to cure them.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and willing to sign a consent form.
- Have one of the listed advanced cancers confirmed by a tissue test within 12 weeks before screening.
- Have lost at least 5% of your weight in 6 months, or at least 2% with a body mass index (BMI) below 20 or muscle loss.
- Be starting or receiving your first cancer treatment meant to ease or control the cancer, with or without radiation. You must not have started the second treatment cycle. Earlier treatment given after surgery must have ended at least 6 months before screening.
- Be able to walk on your own, with a cane or walker if needed, and handle your own basic care. Your activity score must be ECOG 0–2.
- If cancer has spread to your brain, have no symptoms or have completed treatment and recovered from its immediate effects. You must be off steroid treatment and have stable brain and nerve function for at least 4 weeks.
- Be willing and able to stop medicines or store-bought products that could interact with olanzapine before and during the study.
- Follow rules about breastfeeding and birth control. If you can become pregnant, have a negative pregnancy test. If you can become pregnant or produce sperm, do not donate eggs or sperm during the study or for 1 month after.
Who can't join
- Use or plan to use antipsychotic medicines during the study, or have used them within 30 days before joining. Some medicines used to prevent nausea, such as prochlorperazine, are allowed.
- Use medicines or supplements to boost appetite during the restricted period before joining, including megestrol, cannabis products, or steroids equal to at least 5 mg of prednisone daily. Standard steroids to prevent chemotherapy nausea are allowed.
- Have poorly controlled diabetes, such as fasting morning blood sugar of 300 mg/dL or higher or a recent A1c of 8 or higher.
- Have poor liver or kidney function on study tests, or need dialysis. Some exceptions apply to liver tests.
- Get food through a feeding tube or vein, or have a condition or planned procedure that could keep your body from absorbing the study pill.
- Have fluid buildup in your belly that keeps returning, does not respond to treatment, and needs to be drained.
- Have an uncontrolled infection, including COVID-19, or uncontrolled symptoms that make the study unsafe. Symptoms controlled for at least 1 week may be allowed by the study doctor.
- Have another health or mental health condition, or abnormal test result, that makes joining unsafe. This includes current suicidal thoughts or actions, or those within the past year.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 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 Criteria: * 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
Study sites (1)
OR
- OHSU Knight Cancer Institute · Portland, OR 97239Eric Roeland, M.D., FAAHPM, FASCO · Study contact · 503-494-8534 · roeland@ohsu.eduEric Roeland, M.D., FAAHPM, FASCO · Principal investigatorMore trials in Portland