Using olanzapine to help cancer patients regain appetite and manage weight loss
ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
This study is testing if the medication olanzapine can help cancer patients who are losing weight and have a poor appetite feel better and gain weight while they are receiving treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05705492 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of olanzapine in managing cancer cachexia, specifically targeting patients with advanced esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancers who are experiencing appetite loss while undergoing non-curative cancer therapy. Participants will be randomized to receive either olanzapine at two different doses or a placebo over a 12-week period. The primary objective is to assess the proportion of patients achieving more than 5% weight gain, while secondary objectives include evaluating various cancer cachexia-related endpoints such as nutritional status and quality of life. The study also includes optional imaging and blood sample collections to monitor health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic esophagogastric, hepatopancreaticobiliary, colorectal, or lung cancer who have experienced significant weight loss.
Not a fit: Patients who are not experiencing weight loss or those with early-stage cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve appetite and weight management in cancer patients, enhancing their quality of life during treatment.
How similar studies have performed: Other studies have shown promise in using olanzapine for appetite stimulation in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Eric Roeland, M.D., FAAHPM, FASCO — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.