Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jun 17, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two medications, olanzapine and megestrol acetate, to see which one is more effective at helping cancer patients with advanced disease who are experiencing a loss of appetite. The goal is to find ways to improve appetite and prevent weight loss, which can be serious for these patients. Olanzapine is being tested as it may help stimulate appetite better than the usual treatment with megestrol acetate.
To participate in the trial, patients need to be at least 18 years old and have been diagnosed with advanced cancer, along with a noticeable loss of appetite and weight over the past two months. They should not be receiving certain other treatments or have specific health conditions that could complicate their participation. Participants can expect to receive either olanzapine or megestrol acetate and will be monitored for changes in their appetite and weight. It's important for potential participants to understand that the trial involves new treatments, which may have unknown effects, and they will need to follow specific guidelines during the study.
Gender
ALL
Eligibility criteria
- 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)
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Milwaukee, Wisconsin, United States
Jamaica, New York, United States
Flint, Michigan, United States
Edina, Minnesota, United States
Harvey, Illinois, United States
Des Moines, Iowa, United States
La Crosse, Wisconsin, United States
Saint Paul, Minnesota, United States
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Safety Harbor, Florida, United States
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Ann Arbor, Michigan, United States
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Chelsea, Michigan, United States
Danville, Illinois, United States
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Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Ames, Iowa, United States
Canton, Michigan, United States
Glenview, Illinois, United States
Grayslake, Illinois, United States
Sunset Hills, Missouri, United States
Des Moines, Iowa, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Washington, North Carolina, United States
Sandpoint, Idaho, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Detroit, Michigan, United States
Johnson City, Tennessee, United States
Flint, Michigan, United States
Warren, Michigan, United States
Norton, Virginia, United States
Bristol, Virginia, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Des Moines, Iowa, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Aiea, Hawaii, United States
Ewa Beach, Hawaii, United States
Patients applied
Trial Officials
Aminah Jatoi, MD
Study Chair
Mayo Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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