This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom)
* Diagnosis of advanced cancer
* Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day
* The patient must perceive loss of appetite and/or weight as a problem; and have an appetite score of 4 or worse on the "Please rate your appetite…." question that requires a patient response on a 0-10 numeric rating scale
* Not receiving ongoing tube feedings or parenteral nutrition at the time of registration
* Not currently using systemic adrenal steroids (with the exception of short-term dexamethasone within 3 days of chemotherapy for control of chemotherapy side effects)
* No use of androgens, progesterone analogs, or other appetite stimulants within the past month
* Patient should not have poorly controlled hypertension or congestive heart failure at registration
* Patient should not have an obstruction of the alimentary canal, malabsorption, or intractable vomiting (defined as vomiting more than 3 times per day over the preceding week)
* Not currently using olanzapine for another medical condition or had previously used olanzapine for chronic nausea or for any pre-existing psychotic disorder
* Patient should not have had a previous blood clot at any time in the past
* No history of poorly controlled diabetes
* No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications
* No history of hypersensitivity to olanzapine or megestrol acetate
* No COVID-19 infection in the past that, in the opinion of the treating physician, had left patients with compromised taste, which has not resolved at the time of registration
* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 14 days prior to registration is required
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Estimated life expectancy of 3 months or longer
* Serum creatinine =\< 2.0 mg/dL
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
* Fasting glucose \< 140 mg/dL
* Granulocytes \> 1000/hpf
* No treatment with another antipsychotic agent, such as risperidone, quetiapine, clozapine, butyrophenone within 30 days of enrollment
* In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English or Spanish. Sites seeking to enroll Spanish-speaking patients should have access to Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish, and to conduct the weekly phone calls
Exclusion Criteria:
* Psychiatric illness which would prevent the patient from giving informed consent
* Medical condition such as uncontrolled infection (including human immunodeficiency virus \[HIV\]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
* Patients who cannot swallow oral formulations of the agents
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* No presence of a hormone-sensitive tumor, such as breast, endometrial, or prostate cancer (this exclusion criterion is intended to circumvent any confounding antineoplastic effects of megestrol acetate)
Primary outcome measure(s)
Change in appetite — Baseline up to 4 weeks Will be compared between the two study groups (olanzapine versus megestrol acetate) using a 0-10 numerical rating scale. Will be summarized by mean (standard deviation \[SD\]) and median (range) by treatment arm. The difference in appetite change from baseline to 4 weeks of treatment between arms will be estimated along with a 95% confidence interval and will be compared using a t-test or Wilcoxon rank-sum test as appropriate.
Trial sites (293)
Facility
City
Region
Status
Arizona Center for Cancer Care - Gilbert
Gilbert
Arizona
CTCA at Western Regional Medical Center
Goodyear
Arizona
Arizona Center for Cancer Care-Peoria
Peoria
Arizona
Arizona Center for Cancer Care - Phoenix
Phoenix
Arizona
Arizona Center for Cancer Care - Osborn
Scottsdale
Arizona
Arizona Center for Cancer Care - Scottsdale
Scottsdale
Arizona
Arizona Center for Cancer Care-Surprise
Surprise
Arizona
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arkansas
Epic Care-Dublin
Dublin
California
Epic Care Partners in Cancer Care
Emeryville
California
Washington Hospital
Fremont
California
Contra Costa Regional Medical Center
Martinez
California
Bay Area Tumor Institute
Oakland
California
Zuckerberg San Francisco General Hospital
San Francisco
California
Dominican Santa Cruz Hospital
Santa Cruz
California
Epic Care Cyberknife Center
Walnut Creek
California
Rocky Mountain Cancer Centers-Aurora
Aurora
Colorado
Rocky Mountain Cancer Centers-Boulder
Boulder
Colorado
Rocky Mountain Cancer Centers - Centennial
Centennial
Colorado
Rocky Mountain Cancer Centers-Midtown
Denver
Colorado
Rocky Mountain Cancer Centers-Rose
Denver
Colorado
Mountain Blue Cancer Care Center - Swedish
Englewood
Colorado
Rocky Mountain Cancer Centers - Swedish
Englewood
Colorado
Grand Valley Oncology
Grand Junction
Colorado
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Colorado
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Colorado
Rocky Mountain Cancer Centers-Thornton
Thornton
Colorado
Beebe South Coastal Health Campus
Millville
Delaware
Delaware Clinical and Laboratory Physicians PA
Newark
Delaware
Helen F Graham Cancer Center
Newark
Delaware
Medical Oncology Hematology Consultants PA
Newark
Delaware
Beebe Health Campus
Rehoboth Beach
Delaware
Christiana Care Health System-Wilmington Hospital
Wilmington
Delaware
Kaiser Permanente-Capitol Hill Medical Center
Washington D.C.
District of Columbia
Morton Plant Hospital
Clearwater
Florida
Halifax Health Medical Center-Centers for Oncology
Daytona Beach
Florida
Regional Cancer Center-Lee Memorial Health System
Fort Myers
Florida
Halifax Health Center for Oncology - Ormond Beach
Ormond Beach
Florida
South Florida Baptist Hospital
Plant City
Florida
Halifax Health Center for Oncology - Port Orange
Port Orange
Florida
+ 253 more sites — see the full list on the official registry below.
More Alliance for Clinical Trials in Oncology trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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