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RECRUITING

NCT04939090

PHASE3

Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2022-01-03

Completion Date

2027-12-31

Last Updated

2026-03-04

Healthy Volunteers

Conditions

Advanced Malignant Solid Neoplasm Anorexia Hematopoietic and Lymphoid Cell Neoplasm

Interventions

DRUG

Olanzapine

Given PO

DRUG

Megestrol Acetate

Given PO

OTHER

Questionnaire Administration

Ancillary studies

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)

Locations (293)

Arizona Center for Cancer Care - Gilbert

Gilbert, Arizona, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Arizona Center for Cancer Care-Peoria

Peoria, Arizona, United States

Arizona Center for Cancer Care - Phoenix

Phoenix, Arizona, United States

Arizona Center for Cancer Care - Osborn

Scottsdale, Arizona, United States

Arizona Center for Cancer Care - Scottsdale

Scottsdale, Arizona, United States

Arizona Center for Cancer Care-Surprise

Surprise, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Epic Care-Dublin

Dublin, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Washington Hospital

Fremont, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Dominican Santa Cruz Hospital

Santa Cruz, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Kaiser Permanente-Capitol Hill Medical Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

Halifax Health Medical Center-Centers for Oncology

Daytona Beach, Florida, United States

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

Halifax Health Center for Oncology - Ormond Beach

Ormond Beach, Florida, United States

South Florida Baptist Hospital

Plant City, Florida, United States

Halifax Health Center for Oncology - Port Orange

Port Orange, Florida, United States

Mease Countryside Hospital

Safety Harbor, Florida, United States

Saint Anthony's Hospital Cancer Care Center

St. Petersburg, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

Piedmont Newnan Hospital

Newnan, Georgia, United States

Piedmont Henry Hospital

Stockbridge, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza